Hypertrophic Cardiomyopathy Clinical Trial
Official title:
Correlation Between Myocardial Deformation and Coronary Artery Morphology in Patients With Hypertrophic Cardiomyopathy and Analysis of Genetic Factors:A Prospective, Single-center, Case-control Study
NCT number | NCT04830787 |
Other study ID # | TCAHCM |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2017 |
Est. completion date | August 1, 2022 |
Verified date | August 2022 |
Source | Henan Provincial People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Correlation between Myocardial Deformation and Coronary Tortuosity and Analysis of Genetic Factors Among Hypertrophic Cardiomyopathy Patients
Status | Completed |
Enrollment | 302 |
Est. completion date | August 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Subjects must meet all the following inclusion criteria to be eligible for participation in this study 1. 18<age=85; 2. Patients with hypertrophic cardiomyopathy and without hypertrophic cardiomyopathy undergoing coronary angiography and echocardiography; 3. Willing to sign informed consent. Exclusion Criteria: - Subjects who meet any of the following exclusion criteria are not to be enrolled in this study 1. All coronary arteries can not be shown clearly in coronary angiography 2. Prior coronary artery bypass surgery, valve prosthesis 3. Connective tissue disease 4. Cardiac dilatation(left ventricular end diastolic diameter, =55mm male,=50mm female ) 5. Congenital heart failure, LVEF<35% 6. Coronary total occlusion, changes in coronary morphology, such as long stents implantation(=12mm) |
Country | Name | City | State |
---|---|---|---|
China | Central China Fuwai Hospital, Heart Center of Henan Provincal People's Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Henan Provincial People's Hospital |
China,
Barilla F, Romeo F, Rosano GM, Valente A, Reale A. Coronary artery loops and myocardial ischemia. Am Heart J. 1991 Jul;122(1 Pt 1):225-6. — View Citation
Eleid MF, Guddeti RR, Tweet MS, Lerman A, Singh M, Best PJ, Vrtiska TJ, Prasad M, Rihal CS, Hayes SN, Gulati R. Coronary artery tortuosity in spontaneous coronary artery dissection: angiographic characteristics and clinical implications. Circ Cardiovasc Interv. 2014 Oct;7(5):656-62. doi: 10.1161/CIRCINTERVENTIONS.114.001676. Epub 2014 Aug 19. — View Citation
Li Y, Shen C, Ji Y, Feng Y, Ma G, Liu N. Clinical implication of coronary tortuosity in patients with coronary artery disease. PLoS One. 2011;6(8):e24232. doi: 10.1371/journal.pone.0024232. Epub 2011 Aug 31. — View Citation
Maron BJ, McKenna WJ, Danielson GK, Kappenberger LJ, Kuhn HJ, Seidman CE, Shah PM, Spencer WH 3rd, Spirito P, Ten Cate FJ, Wigle ED; Task Force on Clinical Expert Consensus Documents. American College of Cardiology; Committee for Practice Guidelines. European Society of Cardiology. American College of Cardiology/European Society of Cardiology clinical expert consensus document on hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents and the European Society of Cardiology Committee for Practice Guidelines. J Am Coll Cardiol. 2003 Nov 5;42(9):1687-713. Review. — View Citation
Salton CJ, Chuang ML, O'Donnell CJ, Kupka MJ, Larson MG, Kissinger KV, Edelman RR, Levy D, Manning WJ. Gender differences and normal left ventricular anatomy in an adult population free of hypertension. A cardiovascular magnetic resonance study of the Framingham Heart Study Offspring cohort. J Am Coll Cardiol. 2002 Mar 20;39(6):1055-60. — View Citation
Vorobtsova N, Chiastra C, Stremler MA, Sane DC, Migliavacca F, Vlachos P. Effects of Vessel Tortuosity on Coronary Hemodynamics: An Idealized and Patient-Specific Computational Study. Ann Biomed Eng. 2016 Jul;44(7):2228-39. doi: 10.1007/s10439-015-1492-3. Epub 2015 Oct 23. — View Citation
Weidemann F, Mertens L, Gewillig M, Sutherland GR. Quantitation of localized abnormal deformation in asymmetric nonobstructive hypertrophic cardiomyopathy: a velocity, strain rate, and strain Doppler myocardial imaging study. Pediatr Cardiol. 2001 Nov-Dec;22(6):534-7. Epub 2001 Dec 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | coronary artery tortuosity and tortuosity score in hypertrophic cardiomyopathy patients | Severe tortuosity was defined as =2 consecutive curvatures of =180° in a major epicardial coronary artery =2 mm in diameter . Mild tortuosity was defined as either =3 consecutive curvatures of 45° to 90° in a major epicardial coronary artery, or =3 consecutive curvatures of 90° to 180° in an artery <2 mm in diameter. The tortuosity score was calculated as a sum of scores for each major epicardial coronary artery (left anterior descending, left circumflex, right coronary artery) with 0=no tortuosity, 1=mild tortuosity,2=tortuosity, 3=severe tortuosity. We will evaluate if the patients have coronary artery tortuosity and assess the number of tortuosity score for every coronary artery and add the score up for every patients. | six months | |
Primary | prognostic roles of coronary artery tortuosity in hypertrophic cardiomyopathy | retrospectively included HCM patients with echocardiography and coronary angiography (CAG), in Fuwai Central China Cardiovascular Hospital from 1st Dec 2017 to 10th Jun 2021. All patients were followed up until the censoring day of 1st July 2022. The primary outcomes were composite of all-cause death, maglinant arrhythmia, ischemic stroke. Death was documented according to medical records, death certificates, or follow-up questionnaires by family members. Arrhythmia included ventricular fibrillation, sustained ventricular tachycardia, second-degree type II and third-degree atrioventricular block. | 2017/12/01-2022/07/01 | |
Primary | prognostic roles of coronary artery tortuosity in hypertrophic cardiomyopathy | etrospectively included HCM patients with echocardiography and coronary angiography (CAG), in Fuwai Central China Cardiovascular Hospital from 1st Dec 2017 to 10th Jun 2021. All patients were followed up until the censoring day of 1st July 2022. The secondary outcomes were composite of primary outcomes and rehospitalization. | 2017/12/01-2022/07/01 | |
Secondary | myocardial strain and strain rate in hypertrophic cardiomyopathy patients with coronary artery tortuosity | observe the difference of myocardial strain between hypertrophic cardiomyopathy with and without coronary artery tortuosity, Global longitudinal strain (GLS), global longitudinal strain rate (GLSR), global circumferential strain (GCS), global circumferential strain rate (GCSR), global radial strain (GRS), and global radial strain rate (GRSR) of the LV and RV will be calculated and segmental strain and strain rate will also be assessed respectively | six months | |
Secondary | genetic factors(such as genetic mutation site for HCM(MYBPC3,MYH7,ACTC1,TNNI3)) for hypertrophic cardiomyopathy patients with coronary artery tortuosity | do genetic testing, observe the difference for genetic factors such as gene mutation for hypertrophic cardiomyopathy with and without coronary artery tortuosity, all the 40 genes which has been found to be implicated in HCM will be tested, such as MYBPC3, MYH7, TPM1,TNNT2 and TNNI3. | two months |
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