Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve

• Status: Terminated
• Trial end date: 2019-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Adenosine; Regadenoson

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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