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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03249272
Date of registration: 08/08/2017
Prospective Registration: Yes
Primary sponsor: Duke University
Public title: Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve
Scientific title: Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve
Date of first enrolment: September 5, 2017
Target sample size: 31
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT03249272
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Han Kim
Address: 
Telephone:
Email:
Affiliation:  Duke University
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Hypertrophic Cardiomyopathy
Microvascular Ischaemia of Myocardium
Non-ischemic Dilated Cardiomyopathy
Intervention(s)
Drug: Adenosine
Drug: Regadenoson
Primary Outcome(s)
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. [Time Frame: The prevalence of MVD will be determined based on the findings at the time of the scan on Day 1 of the study.]
Secondary Outcome(s)
CMR Measurement of Global Perfusion Reserve Ratio [Time Frame: The global perfusion ratio will be calculated from the measurements obtained at the time of the scan on Day 1 of the study.]
The Association Between Global Perfusion Reserve (GPR) Ratio and Regional Myocardial Scarring. [Time Frame: 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.]
Secondary ID(s)
Pro00082447
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 16/09/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT03249272
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