Trial · NCT03249272
Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve
NCT03249272, Phase 4, Terminated, Duke University; results first posted 2020-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve. Trials, record NCT03249272. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03249272
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve
- NCT number
- NCT03249272
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 31 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Hypertrophic Cardiomyopathy, Non-ischemic Dilated Cardiomyopathy, Microvascular Ischaemia of Myocardium
- Interventions
- Regadenoson, Adenosine
- First posted
- 2017-08-15
- Last updated
- 2020-09-16
- Results first posted
- 2020-09-16
- Limitations and caveats
- Slow recruitment led to the end of the study.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Prevalence of Microvascular Dysfunction (MVD) by a CMR Measurement of Whole-heart (Global) Perfusion Reserve Ratio in Patients With Hypertrophic Cardiomyopathy, Non-ischemic Cardiomyopathy, and Controls. | The prevalence of MVD will be determined based on the findings at the time of the scan on Day 1 of the study. | Prevalence of microvascular dysfunction as determined by the CMR measure of global perfusion reserve ratio (GPR) in each these patient groups. MVD was considered present when either GPR was \<2.0 or regional stress perfusion abnormalities were present. In order to calculate this ratio, coronary sinus flow was measured twice: 1. prior to the the administration of adenosine/regadenoson 2. during the administration of adenosine/regadenoson GPR is a ratio of coronary sinus flow during the administration adenosine/regadenoson divided by the baseline coronary sinus flow measured prior to the administration. Regional perfusion abnormalities will be assessed at the time of adenosine/regadenoson administration. |
| Secondary | CMR Measurement of Global Perfusion Reserve Ratio | The global perfusion ratio will be calculated from the measurements obtained at the time of the scan on Day 1 of the study. | Comparison of the CMR measure of global perfusion reserve ratio (GPR) in each these patient groups. In order to calculate this ratio, coronary sinus flow was measured twice: 1. prior to the the administration of adenosine/regadenoson 2. during the administration of adenosine/regadenoson |
| Secondary | The Association Between Global Perfusion Reserve (GPR) Ratio and Regional Myocardial Scarring. | Both global perfusion ratio and the presence of regional scarring will be determined/measured from the images obtained during the scan on Day 1 of the study. | Relationship between global perfusion reserve ratio and regional myocardial scarring. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Prevalence of Microvascular Dysfunction (MVD) by a CMR Measurement of Whole-heart (Global) Perfusion Reserve Ratio in Patients With Hypertrophic Cardiomyopathy, Non-ischemic Cardiomyopathy, and Controls. | The prevalence of MVD will be determined based on the findings at the time of the scan on Day 1 of the study. | Due to the slow pace of recruitment, the sponsor withdrew funding for the study. Of the expected 75 participants, 31 were recruited. As was pre-specified, the regadenoson and adenosine groups were combined for analysis as these interventions are interchangeable. | Percentage of group with MVD | NUMBER |
| SECONDARY | CMR Measurement of Global Perfusion Reserve Ratio | The global perfusion ratio will be calculated from the measurements obtained at the time of the scan on Day 1 of the study. | As was pre-specified, the regadenoson and adenosine groups were combined for analysis as these interventions are interchangeable. | ratio | MEDIAN |
| SECONDARY | The Association Between Global Perfusion Reserve (GPR) Ratio and Regional Myocardial Scarring. | Both global perfusion ratio and the presence of regional scarring will be determined/measured from the images obtained during the scan on Day 1 of the study. | As was pre-specified, the regadenoson and adenosine groups were combined for analysis as these interventions are interchangeable. One of the control patients was not able to hold his/her breath, and no image was acquired for stress perfusion myocardial flow. Thus, global perfusion reserve could not be calculated. | Global perfusion reserve ratio | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Prevalence of Microvascular Dysfunction (MVD) by a CMR Measurement of Whole-heart (Global) Perfusion Reserve Ratio in Patients With Hypertrophic Cardiomyopathy, Non-ischemic Cardiomyopathy, and Controls. | Hypertrophic Cardiomyopathy | 79 | Percentage of group with MVD | ||
Prevalence of Microvascular Dysfunction (MVD) by a CMR Measurement of Whole-heart (Global) Perfusion Reserve Ratio in Patients With Hypertrophic Cardiomyopathy, Non-ischemic Cardiomyopathy, and Controls. | Non-ischemic Dilated Cardiomyopathy | 33.3 | Percentage of group with MVD | ||
Prevalence of Microvascular Dysfunction (MVD) by a CMR Measurement of Whole-heart (Global) Perfusion Reserve Ratio in Patients With Hypertrophic Cardiomyopathy, Non-ischemic Cardiomyopathy, and Controls. | Control | 20 | Percentage of group with MVD | ||
| CMR Measurement of Global Perfusion Reserve Ratio | Hypertrophic Cardiomyopathy | 2.99 | Inter-Quartile Range 1.87 to 4.65 | ratio | |
| CMR Measurement of Global Perfusion Reserve Ratio | Non-ischemic Dilated Cardiomyopathy | 3.04 | Inter-Quartile Range 2.64 to 3.61 | ratio | |
| CMR Measurement of Global Perfusion Reserve Ratio | Control | 3.83 | Inter-Quartile Range 2.42 to 4.34 | ratio | |
| The Association Between Global Perfusion Reserve (GPR) Ratio and Regional Myocardial Scarring. | Hypertrophic Cardiomyopathy - Scarring | 3.19 | Standard Deviation 1.71 | Global perfusion reserve ratio | |
| The Association Between Global Perfusion Reserve (GPR) Ratio and Regional Myocardial Scarring. | Hypertrophic Cardiomyopathy - Without Scarring | 5.91 | Standard Deviation 4.09 | Global perfusion reserve ratio | |
| The Association Between Global Perfusion Reserve (GPR) Ratio and Regional Myocardial Scarring. | Non-ischemic Dilated Cardiomyopathy - Scarring | 3.16 | Standard Deviation 0.65 | Global perfusion reserve ratio | |
| The Association Between Global Perfusion Reserve (GPR) Ratio and Regional Myocardial Scarring. | Control - Without Scarring | 3.53 | Standard Deviation 1.26 | Global perfusion reserve ratio |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hypertrophic Cardiomyopathy | 19 | |
| Overall Study | STARTED | Non-ischemic Dilated Cardiomyopathy | 6 | |
| Overall Study | STARTED | Control | 6 | |
| Overall Study | COMPLETED | Hypertrophic Cardiomyopathy | 19 | |
| Overall Study | COMPLETED | Non-ischemic Dilated Cardiomyopathy | 6 | |
| Overall Study | COMPLETED | Control | 6 | |
| Overall Study | NOT COMPLETED | Hypertrophic Cardiomyopathy | 0 | |
| Overall Study | NOT COMPLETED | Non-ischemic Dilated Cardiomyopathy | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hypertrophic Cardiomyopathy - Adenosine | 0 | 10 |
| Total, all-cause mortality | Hypertrophic Cardiomyopathy - Regadenoson | 0 | 9 |
| Total, all-cause mortality | Non-ischemic Dilated Cardiomyopathy - Adenosine | 0 | 2 |
| Total, all-cause mortality | Non-ischemic Dilated Cardiomyopathy - Regadenoson | 0 | 4 |
| Total, all-cause mortality | Control - Adenosine | 0 | 3 |
| Total, all-cause mortality | Control - Regadenoson | 0 | 3 |
| Total, other adverse events | Hypertrophic Cardiomyopathy - Adenosine | 0 | 10 |
| Total, other adverse events | Hypertrophic Cardiomyopathy - Regadenoson | 0 | 9 |
| Total, other adverse events | Non-ischemic Dilated Cardiomyopathy - Adenosine | 0 | 2 |
| Total, other adverse events | Non-ischemic Dilated Cardiomyopathy - Regadenoson | 0 | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers5
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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