Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve
Stopped early · Phase 4
Conditions studied: Hypertrophic Cardiomyopathy, Non-ischemic Dilated Cardiomyopathy, Microvascular Ischaemia of Myocardium
In brief
The aim of this study is to assess microvascular function as determined by a cardiovascular magnetic resonance measurement of whole-heart (global) perfusion reserve. The goal is to determine the prevalence of MVD in two common forms of non-ischemic cardiomyopathy, hypertrophic cardiomyopathy (HCM) and idiopathic dilated cardiomyopathy (IDCM). The hypothesis that an optimized technique will provide robust detection of MVD and that a multifaceted approach will provide new insights into the pathophysiology of MVD, including the influence of myocardial scarring upon the presence and severity of MVD.
Key facts
- Study ID
- NCT03249272
- Run by
- Duke University
- People needed
- 31
- Starts
- 2017-09-05
- Expected to finish
- 2019-03-31
- Last updated by the study team
- 2020-09-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men or women aged 18 years or older
- Cardiomyopathy patients
- Patients presenting for CMR with the clinical diagnosis of hypertrophic cardiomyopathy based on left ventricular wall thickness of at least ≥15 mm in the absence of any other cardiac or systemic cause of hypertrophy
- Patients presenting for CMR with the clinical diagnosis of idiopathic dilated cardiomyopathy based upon left ventricular ejection fraction ≤40%, LV end-diastolic diameter ≥55 mm or left ventricular end-systolic diameter ≤45 mm, and the absence of coronary stenoses on angiography.
- Control patients
- Patients presenting for CMR without evidence of obstructive coronary artery disease either by coronary angiography or stress testing.
You may not qualify if…
- Decompensated heart failure or hemodynamic instability
- Prior coronary revascularization (PCI or CABG) or myocardial infarction (as evidenced by previously elevated CPK-MB or troponin levels)
- Accelerating angina or unstable angina
- Inability to physically tolerate MRI or implanted objects that are MRI incompatible
- Inability to provide written informed consent obtained at time of study enrollment.
- Severe claustrophobia
- Advanced heart block or sinus node dysfunction
- Hypersensitivity or allergic reaction to regadenoson or adenosine
- Hypotension
- Active bronchospasm or history of hospitalization due to bronchospasm
- History of seizures
- Recent cerebrovascular accident
- Use of dipyridamole within the last 5 days
- Contraindication to aminophylline
- Severe renal insufficiency with estimated glomerular filtration rate <30 ml/min/ 1.73 m2
- Pregnant or nursing
Where it is running
- Duke Cardiovascular Magnetic Resonance Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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