Trial · NCT03715790
Improve SCA Bridge Study
NCT03715790, Completed, Medtronic Cardiac Rhythm and Heart Failure; results first posted 2024-01-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Improve SCA Bridge Study. Trials, record NCT03715790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03715790
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improve SCA Bridge Study
- NCT number
- NCT03715790
- Status
- Completed
- Enrollment
- 1,491 participants, actual
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Conditions
- Sudden Cardiac Arrest, Acute Myocardial Infarction
- Interventions
- EP referred group, Non-Referred group
- First posted
- 2018-10-23
- Last updated
- 2024-01-16
- Results first posted
- 2024-01-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management | 3-months post-MI to 12-months post-MI | The numerator for this endpoint will be defined as the number of patients who met the clinician's determination to refer the subject for SCD risk stratification and management at any of the three follow-up visits. The denominator for this endpoint is the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this one arm. No hypotheses were tested for this endpoint. |
| Secondary | Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI | 3-months post-MI to 12-months post-MI | The numerator for this endpoint will be the number of subjects who were indicated for an ICD/CRT-D device during any of the three follow-up visits. The denominator will be the number of subjects who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint. |
| Secondary | Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI. | 3-months post-MI to 12-months post-MI | The numerator for this endpoint will be the number of subjects who received an ICD/CRT-D device during any of the three follow-up visits. The denominator for this endpoint will be the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint. |
| Secondary | Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | 3-months post-MI to 12-months post-MI | The outcome measure will be the percentage of patients with ICD indication, who were not referred, refused referral or refused implant. The denominator will count all patients with at least one of the below: 1. a reduced ejection fraction, as measured by the Left Ventricular Ejection Fraction (LVEF) being lower or equal than 40%. \> 2. ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities as measured by ECGs. \> 3. unexplained syncope, clinically significant palpitations or symptomatic bradycardia as assessed by the physician. \> The numerator will count the patients included in the denominator who were not referred, refused referral or refused implant of an ICD/CRT-D. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the referral process results in the single arm of enrolled patients, with analysis performed within this arm. No hypotheses were tested for this endpoint. |
| Secondary | Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality | Enrollment to 12-months post-MI | The numerator for this endpoint will be the number of patients who experience cardiovascular mortality. The denominator will be the number of patients enrolled in the study. No hypotheses were tested for this endpoint. |
| Secondary | Evolution of the Ejection Fraction Over the Immediate Period of Post MI | Enrollment to 3-months post-MI | The Left Ventricular Ejection Fraction (LVEF) will be measured acutely post MI (≤14 days after MI onset) and chronically (40-90 days). The acute measurement will occur over all 1491 subjects assessed at baseline, while the chronic assessment will be measured over the 1046 subjects with a 3-month LVEF assessment. This outcome will compare the average LVEF, by percent, between these two phases. No hypotheses were tested for this endpoint. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management | 3-months post-MI to 12-months post-MI | Enrolled subjects who were evaluated at 3-month follow up to determine if they met referral criteria or did not meet referral criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI | 3-months post-MI to 12-months post-MI | Enrolled subjects who were evaluated at 3-month follow up to determine if they met referral criteria or did not meet referral criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI. | 3-months post-MI to 12-months post-MI | Enrolled subjects who were evaluated at 3-month follow up to determine if they met referral criteria or did not meet referral criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | 3-months post-MI to 12-months post-MI | Enrolled patients who, at the 3-month visit, met the criteria for referral for SCD risk stratification. These criteria include a reduced ejection fraction less than or equal to 40%, ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities, or unexplained syncope, clinically significant palpitations or symptomatic bradycardia. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality | Enrollment to 12-months post-MI | Enrolled subjects | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Evolution of the Ejection Fraction Over the Immediate Period of Post MI | Enrollment to 3-months post-MI | Acute LVEF measurements occurred at baseline on 1491 subjects. Chronic LVEF measurements were collected at the 3-month follow up on 1046 subjects (104 subjects were exited before the 3-month follow up, and 341 subjects did not have their LVEF measurement taken at the 3-month follow up). | Percentage of LV stroke volume | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management | Referred Subjects | 236 | Participants | ||
| Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management | Not Referred Subjects | 934 | Participants | ||
| Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI | Post-acute MI Subjects | 127 | Participants | ||
| Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI. | Post-acute MI Subjects | 18 | Participants | ||
| Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Subjects Who Met Referral Criteria | Number of patients who who were not referred, refused referral or refused implant of an ICD/CRT-D | 162 | Participants | |
| Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Subjects Who Met Referral Criteria | Number of patients not referred due to the patient deemed referral not necessary. | 21 | Participants | |
| Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Subjects Who Met Referral Criteria | Number of patients not referred due to the patient was asymptomatic. | 42 | Participants | |
| Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Subjects Who Met Referral Criteria | Number of patients not referred due to the physician preferred continuing with medication. | 75 | Participants | |
| Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Subjects Who Met Referral Criteria | Number of patients who refused implant due to patient does not want risk associated with implant. | 40 | Participants | |
| Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Subjects Who Met Referral Criteria | Number of patients who refused implant due to patient does not believe in benefit of ICD/CRT-D. | 36 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 3-months | STARTED | Post-acute MI Patients Who Are Candidates for SCA Risk Stratification | 1,491 | |
| 3-months | COMPLETED | Post-acute MI Patients Who Are Candidates for SCA Risk Stratification | 1,170 | |
| 3-months | NOT COMPLETED | Post-acute MI Patients Who Are Candidates for SCA Risk Stratification | 321 | |
| 6-months | STARTED | Post-acute MI Patients Who Are Candidates for SCA Risk Stratification | 1,170 | |
| 6-months | COMPLETED | Post-acute MI Patients Who Are Candidates for SCA Risk Stratification | 916 | |
| 6-months | NOT COMPLETED | Post-acute MI Patients Who Are Candidates for SCA Risk Stratification | 254 | |
| 12-months | STARTED | Post-acute MI Patients Who Are Candidates for SCA Risk Stratification | 916 | |
| 12-months | COMPLETED | Post-acute MI Patients Who Are Candidates for SCA Risk Stratification | 887 | |
| 12-months | NOT COMPLETED | Post-acute MI Patients Who Are Candidates for SCA Risk Stratification | 29 |
Source ClinicalTrials.gov
Adverse events66
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 | Angina Pectoris | Cardiac disorders | Enrolled Subjects | 6 | 1,491 | 6 |
| other | Arteriosclerosis Coronary Artery | Cardiac disorders | Enrolled Subjects | 1 | 1,491 | 1 |
| other | Atrioventricular Block | Cardiac disorders | Enrolled Subjects | 1 | 1,491 | 1 |
| other | Cardiac Aneurysm | Cardiac disorders | Enrolled Subjects | 1 | 1,491 | 1 |
| other | Cardiac Ventricular Thrombosis | Cardiac disorders | Enrolled Subjects | 4 | 1,491 | 4 |
| other | Dizziness Postural | Nervous system disorders | Enrolled Subjects | 1 | 1,491 | 1 |
| other | Syncope | Nervous system disorders | Enrolled Subjects | 1 | 1,491 | 1 |
| other | Transient Ischaemic Attack | Nervous system disorders | Enrolled Subjects | 1 | 1,491 | 1 |
| other | Acute Kidney Injury | Renal and urinary disorders | Enrolled Subjects | 1 | 1,491 | 1 |
| other | Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | Enrolled Subjects | 1 | 1,491 | 1 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enrolled Subjects | 88 | 1,491 |
| Total, other adverse events | Enrolled Subjects | 18 | 1,491 |
| Total, serious adverse events | Enrolled Subjects | 180 | 1,491 |
Source ClinicalTrials.gov
Papers5
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Referred Subjects vs Not Referred Subjects: Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management |
Source Trial comparisons
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03715790
GET https://conductscience.org/api/trials/v1/NCT03715790/events?page=2