Trial · NCT00162370
A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease
NCT00162370, Phase 4, Completed, Lantheus Medical Imaging; results first posted 2016-12-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease. Trials, record NCT00162370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00162370
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease
- NCT number
- NCT00162370
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 400 participants, actual
- Lead sponsor
- Lantheus Medical Imaging
- Conditions
- Coronary Artery Disease, Heart Disease
- Interventions
- Perflutren Lipid Microsphere Injectable Suspension
- First posted
- 2005-09-13
- Last updated
- 2021-03-15
- Results first posted
- 2016-12-08
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up | 2 year and 5 year follow up | Peri- or post-menopausal female participants with an intermediate pre-test likelihood of coronary artery disease (CAD) received a Definity contrast-enhanced stress echocardiography study at baseline using either treadmill exercise or dobutamine stresss. Images were evaluated for wall motion abnormalities. The results were compared to patient history on 2-year and 5-year follow up to identify the potential of stress echocardiography for predicting those at higher risk of experiencing future cardiac events. Major adverse cardiac events (MACE) are defined as * Cardiac death * Myocardial infarction * Cardiac revascularization (PCI or CABG) * Hospitalization for chest pain or to rule out myocardial infarction * Development of typical angina * Development of heart failure |
| Secondary | Number of Participants With Abnormal ECG and With Major Adverse Cardiac Events (MACE) at 2 Year Follow-Up | 2-year follow-up | Prognostic value of stress ECG testing for identifying female patients at increased risk of major adverse cardiac events (MACE) at 2-year follow-up Peri- or post-meopausal female subjects with an intermediate pre-test likelihood of coronary artery disease (CAD) received resting ECG at baseline. ECG was evaluated as normal or abnormal. The results were compared to patient history on 2-year follow up to identify the potential for ECG to predict those at higher risk of experiencing future cardiac events. Major adverse cardiac events (MACE) are defined as * Cardiac death * Myocardial infarction * Cardiac revascularization (PCI or CABG) * Hospitalization for chest pain or to rule out myocardial infarction * Development of typical angina * Development of heart failure |
| Secondary | Change in Brain Natriuretic Peptide (BNP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. | 2 year follow up | The value of exercise-induced changes in blood concentration of cardiac peptide, brain natriuretic peptide (BNP in pg/mL in blood), was assessed in identifying patients with cardiac events at 2-year follow-up. The change in mean BNP blood concentration from rest to stress at baseline is summarized using number of subjects with and without MACE at 2-year follow-up Major adverse cardiac events (MACE) are defined as * Cardiac death * Myocardial infarction * Cardiac revascularization (PCI or CABG) * Hospitalization for chest pain or to rule out myocardial infarction * Development of typical angina * Development of heart failure |
| Secondary | Change in Atrial Natriuretic Peptide (ANP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. | 2 year follow up | The value of exercise-induced changes in blood concentration of cardiac peptide, atrial natriuretic peptide (ANP in pg/mL in blood), was assessed in identifying patients with cardiac events at 2-year follow-up. The change in mean ANP blood concentration from rest to stress at baseline is summarized using number of subjects with and without major adverse cardiac events (MACE) at 2-year follow-up. Major adverse cardiac events (MACE) are defined as * Cardiac death * Myocardial infarction * Cardiac revascularization (PCI or CABG) * Hospitalization for chest pain or to rule out myocardial infarction * Development of typical angina * Development of heart failure |
| Secondary | Change in Brachial Artery Reactivity Was Assessed in in a Subset of Participants With and Without Major Adverse Cardiac Events at 2-year and 5-year Follow-up. | 2 year and 5 year follow up | A subset of the study population of peri- or post-meopausal female participants with an intermediate pre-test likelihood of coronary artery disease (CAD) was assessed for brachial artery reactivity at baseline. Brachial diameter was assessed using ultrasound and a pressure cuff both before and after administration of sublingual nitroglycerin. The results were compared to patient history on 2-year and 5-year follow up to identify the potential for brachial artery reactivity to predict those at higher risk of experiencing future cardiac events.The brachial artery reactivity was summarized using number of subjects with and without MACE on follow-up. Major adverse cardiac events (MACE) are defined as * Cardiac death * Myocardial infarction * Cardiac revascularization (PCI or CABG) * Hospitalization for chest pain or to rule out myocardial infarction * Development of typical angina * Development of heart failure |
| Secondary | Mean Baseline Calcium Score of Participants With and Without Major Cardiac Events at 2-year Follow up. | 2 year follow up | Coronary artery calcium scoring assesses calcification of the coronary arteries using electron-beam computed tomography (EBCT). It is a sum of lesion scores of area and density above a threshold density. There is no intrinsic upper limit to the calcium score but values above 1000 may not be measurable. A subset of peri- or post-meopausal females with an intermediate pre-test likelihood of coronary artery disease (CAD) received resting EBCT at baseline. Images were evaluated for calcium score and results compared to patient history on 2-year follow up, Mean calcium score with confidence interval was summarized for subjects with and without major cardiac events (MACE) at 2-year follow up. Calcium score for general population: Score Description Relative Risk 0 No evidence of CAD 0 1-112 Average Risk of CAD 1.9 100-400 Moderate risk of CAD 4.3 400-999 High risk of CAD 7.2 1000 Very high risk of CAD 10.8 |
| Secondary | The Presence of Wall Motion Abnormalities on Definity Stress Echocardiography Assessed for Participants With Both Normal and Abnormal Angiography | 60 days | In the sub-set of efficacy-evaluable participants who underwent clinically indicated coronary angiography, the accuracy of exercise echocardiography vs. angiography was determined for the detection of CAD. Positive angiography was defined as any stenosis greater than or equal to 50% in any vessel. Wall motion index change indicating abnormal motion was defined as greater than or equal to 13% in 2 or more segments. Angiography was required to have taken place within 60 days following stress echocardiography. |
| Secondary | Participants With Positive and Negative Angiography Compared With Their ECG Results | 60 days | In the sub-set of efficacy-evaluable participants who underwent clinically indicated coronary angiography, the accuracy of exercise ECG vs. angiography was determined for the detection of CAD. Positive angiography was defined as any stenosis greater than or equal to 50% in any vessel. |
| Secondary | Number of Participants With Abnormal ECG and With Future Major Adverse Cardiac Events (MACE) at 5 Years Follow-Up | 5 year follow up | Prognostic value of stress ECG testing for identifying female patients at increased risk of major adverse cardiac events (MACE) at 5-year follow-up Peri- or post-meopausal female participants with an intermediate pre-test likelihood of coronary artery disease (CAD) received resting ECG at baseline. ECG was evaluated as normal or abnormal. The results were compared to patient history on 5-year follow up to identify the potential for ECG to predict those at higher risk of experiencing future major adverse cardiac events (MACE) at 5-year follow up. Major adverse cardiac events (MACE) are defined as * Cardiac death * Myocardial infarction * Cardiac revascularization (PCI or CABG) * Hospitalization for chest pain or to rule out myocardial infarction * Development of typical angina * Development of heart failure |
| Secondary | Change in Brain Natriuretic Peptide (BNP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up. | 5 year follow up | The value of exercise-induced changes in blood concentration of the cardiac peptide, brain natriuretic peptide (BNP in pg/mL in blood), was assessed in identifying patients with cardiac events at 5-year follow-up. The change in mean BNP blood concentration at baseline from rest to stress is summarized using number of participants with and without MACE at 5-year follow up. Major adverse cardiac events (MACE) are defined as * Cardiac death * Myocardial infarction * Cardiac revascularization (PCI or CABG) * Hospitalization for chest pain or to rule out myocardial infarction * Development of typical angina * Development of heart failure |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up | 2 year and 5 year follow up | Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and participated in 2 year or 5 year follow up | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal ECG and With Major Adverse Cardiac Events (MACE) at 2 Year Follow-Up | 2-year follow-up | Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and participated in 2 year follow up | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Brain Natriuretic Peptide (BNP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. | 2 year follow up | Participants with valid BNP measurements at both rest and stress and who participated in 2-year follow up | pg/mL | MEAN |
| SECONDARY | Change in Atrial Natriuretic Peptide (ANP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. | 2 year follow up | Participants with valid ANP measurements at both rest and stress who participated in 2-year follow up | pg/mL | MEAN |
| SECONDARY | Change in Brachial Artery Reactivity Was Assessed in in a Subset of Participants With and Without Major Adverse Cardiac Events at 2-year and 5-year Follow-up. | 2 year and 5 year follow up | Subjects with valid brachial artery diameter asurements at both rest and stress. Note that among the subjects in the trial who had MACE either at 2 year or 5 years, none had been assessed for brachial artery reactivity. | Percentage | NUMBER |
| SECONDARY | Mean Baseline Calcium Score of Participants With and Without Major Cardiac Events at 2-year Follow up. | 2 year follow up | Participants with EBCT-based calcium score assessment at baseline who participated in 2-year follow up | score on a scale (calcium score) | MEAN |
| SECONDARY | The Presence of Wall Motion Abnormalities on Definity Stress Echocardiography Assessed for Participants With Both Normal and Abnormal Angiography | 60 days | Subjects who underwent both rest and stress Definity-enhanced echocardiography and coronary angiography within 60 days | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With Positive and Negative Angiography Compared With Their ECG Results | 60 days | Subjects who underwent exercise ECG testing and coronary angiography within 60 days | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal ECG and With Future Major Adverse Cardiac Events (MACE) at 5 Years Follow-Up | 5 year follow up | Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and 2 and/or 5 year follow up | Percent of participants | NUMBER |
| SECONDARY | Change in Brain Natriuretic Peptide (BNP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up. | 5 year follow up | Subjects with valid BNP measurements at both rest and stress | pg/mL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up | Definity | Abnormal contrast stress echo and any major cardiac event at 2 year follow up | 2 | Participants | |
| Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up | Definity | Normal contrast stress echo and any major cardiac event at 2 year follow up | 1 | Participants | |
| Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up | Definity | Abnormal contrast stress echo and any major cardiac event at 5 year follow up | 1 | Participants | |
| Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up | Definity | Normal contrast stress echo and any major cardiac event at 5 year follow up | 5 | Participants | |
| Number of Participants With Abnormal ECG and With Major Adverse Cardiac Events (MACE) at 2 Year Follow-Up | Definity | Number of subjects with abnormal stress ECG at baseline who had MACE at 2 years | 3 | Participants | |
| Number of Participants With Abnormal ECG and With Major Adverse Cardiac Events (MACE) at 2 Year Follow-Up | Definity | Number of subjects with abnormal stress ECG at baseline who did not have MACE at 2 years | 15 | Participants | |
| Change in Brain Natriuretic Peptide (BNP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. | Definity | Change of BNP from rest to stress in subjects without major cardiac events at 2 year followup | 5.2 | 95% Confidence Interval 0.61 to 9.79 | pg/mL |
| Change in Brain Natriuretic Peptide (BNP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. | Definity | Change of BNP from rest to stress in subjects with major cardiac events at 2 year followup | 10.7 | 95% Confidence Interval -32.5 to 53.9 | pg/mL |
| Change in Atrial Natriuretic Peptide (ANP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. | Definity | Change of ANP from rest to stress in subjects without major cardiac events at 2-year follow-up | 5.9 | 95% Confidence Interval -98.81 to 110.61 | pg/mL |
| Change in Atrial Natriuretic Peptide (ANP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. | Definity | Change of ANP from rest to stress in subjects with major cardiac events at 2-year follow-up | 101 | 95% Confidence Interval -716.32 to 918.32 | pg/mL |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Completed Echocardiography Imaging | STARTED | Definity | 366 | |
| Completed Echocardiography Imaging | COMPLETED | Definity | 366 | |
| Completed Echocardiography Imaging | NOT COMPLETED | Definity | 0 | |
| Efficacy Population | STARTED | Definity | 366 | |
| Efficacy Population | COMPLETED | Definity | 315 | |
| Efficacy Population | NOT COMPLETED | Definity | 51 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Back Disorder | Musculoskeletal and connective tissue disorders | Definity | 1 | 400 | 1 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Definity | 3 | 400 | 3 |
| other | Muscle Spasm | Musculoskeletal and connective tissue disorders | Definity | 1 | 400 | 1 |
| other | Headache | Nervous system disorders | Definity | 1 | 400 | 1 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Definity | 1 | 400 | 1 |
| other | Urticaria NOS | Skin and subcutaneous tissue disorders | Definity | 1 | 400 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Definity | ||
| Total, other adverse events | Definity | 6 | 400 |
| Total, serious adverse events | Definity | 0 | 400 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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