Status:
TERMINATED
Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve
Lead Sponsor:
Duke University
Conditions:
Hypertrophic Cardiomyopathy
Non-ischemic Dilated Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 preva...
Detailed Description
Coronary microvascular dysfunction (MVD) has been implicated as an important marker of cardiac risk and has been thought to directly contribute to the pathogenesis of a wide variety of cardiomyopathie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03249272
Start Date
September 5 2017
End Date
March 31 2019
Last Update
September 16 2020
Active Locations (1)
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1
Duke Cardiovascular Magnetic Resonance Center
Durham, North Carolina, United States, 27110