Hypertrophic Cardiomyopathy Clinical Trial
Official title:
Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve
Verified date | August 2020 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 31 |
Est. completion date | March 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke Cardiovascular Magnetic Resonance Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Camici PG, Crea F. Coronary microvascular dysfunction. N Engl J Med. 2007 Feb 22;356(8):830-40. Review. — View Citation
Camici PG, d'Amati G, Rimoldi O. Coronary microvascular dysfunction: mechanisms and functional assessment. Nat Rev Cardiol. 2015 Jan;12(1):48-62. doi: 10.1038/nrcardio.2014.160. Epub 2014 Oct 14. Review. — View Citation
Choudhury L, Mahrholdt H, Wagner A, Choi KM, Elliott MD, Klocke FJ, Bonow RO, Judd RM, Kim RJ. Myocardial scarring in asymptomatic or mildly symptomatic patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 2002 Dec 18;40(12):2156-64. — View Citation
Klem I, Greulich S, Heitner JF, Kim H, Vogelsberg H, Kispert EM, Ambati SR, Bruch C, Parker M, Judd RM, Kim RJ, Sechtem U. Value of cardiovascular magnetic resonance stress perfusion testing for the detection of coronary artery disease in women. JACC Cardiovasc Imaging. 2008 Jul;1(4):436-45. doi: 10.1016/j.jcmg.2008.03.010. — View Citation
Klem I, Heitner JF, Shah DJ, Sketch MH Jr, Behar V, Weinsaft J, Cawley P, Parker M, Elliott M, Judd RM, Kim RJ. Improved detection of coronary artery disease by stress perfusion cardiovascular magnetic resonance with the use of delayed enhancement infarction imaging. J Am Coll Cardiol. 2006 Apr 18;47(8):1630-8. Epub 2006 Mar 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 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: prior to the the administration of adenosine/regadenoson 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. |
The prevalence of MVD will be determined based on the findings at the time of the scan on Day 1 of the study. | |
Secondary | CMR Measurement of Global Perfusion Reserve Ratio | 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: prior to the the administration of adenosine/regadenoson during the administration of adenosine/regadenoson |
The global perfusion ratio will be calculated from the measurements obtained at the time of the scan on Day 1 of the study. | |
Secondary | The Association Between Global Perfusion Reserve (GPR) Ratio and Regional Myocardial Scarring. | Relationship between global perfusion reserve 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. |
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