Correlation Between Myocardial Deformation and Coronary Artery Tortuosity in Patients With Hypertrophic Cardiomyopathy

NCT04830787 | Completed DMC

• 1 other identifier: TCAHCM
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

Correlation between Myocardial Deformation and Coronary Tortuosity and Analysis of Genetic Factors Among Hypertrophic Cardiomyopathy Patients

Conditions

Myocardial Deformation; Coronary Artery Anomaly; Hypertrophic Cardiomyopathy; Genetic Mutation; Prognosis

Keywords

hypertrophic cardiomyopathy; tortuosity of coronary arteries; myocardial strain; prognosis; genetic mutation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• myocardial strain and strain rate in hypertrophic cardiomyopathy patients with coronary artery tortuosity

  six months

• genetic factors(such as genetic mutation site for HCM(MYBPC3,MYH7,ACTC1,TNNI3)) for hypertrophic cardiomyopathy patients with coronary artery tortuosity

  two months

Study Arms (2)

hypertrophic cardiomyopathy

patients with hypertrophic cardiomyopathy

Other: no intervention

control without hypertrophic cardiomyopathy

controls without hypertrophic cardiomyopathy

Interventions

no intervention OTHER

there is no intervention, we just chose patients diagnosed with hypertrophic cardiomyopathy and underwent CAG, and patients without hypertrophic cardiomyopathy as control ,the two groups are matched with age, gender and hypertension.

hypertrophic cardiomyopathy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with hypertrophic cardiomyopathy and without hypertrophic cardiomyopathy undergoing coronary angiography and echocardiography

You may qualify if:

• \<age≤85；
• Patients with hypertrophic cardiomyopathy and without hypertrophic cardiomyopathy undergoing coronary angiography and echocardiography;
• Willing to sign informed consent.

You may not qualify if:

• All coronary arteries can not be shown clearly in coronary angiography
• Prior coronary artery bypass surgery, valve prosthesis
• Connective tissue disease
• Cardiac dilatation(left ventricular end diastolic diameter, ≥55mm male，≥50mm female )
• Congenital heart failure, LVEF\<35%
• Coronary total occlusion, changes in coronary morphology, such as long stents implantation（≥12mm）

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Central China Fuwai Hospital, Heart Center of Henan Provincal People's Hospital

Zhengzhou, Henan, 450000, China

Location

Related Publications (7)

• 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.

  PMID: 21904618 BACKGROUND

• 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.

  PMID: 25138034 BACKGROUND

• 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. doi: 10.1016/0002-8703(91)90781-c. No abstract available.

  PMID: 2063741 BACKGROUND

• 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.

  PMID: 26498931 BACKGROUND

• 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. doi: 10.1016/s0735-1097(03)00941-0. No abstract available.

  PMID: 14607462 BACKGROUND

• 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. doi: 10.1007/s002460010293. Epub 2001 Dec 4.

  PMID: 11894166 BACKGROUND

• 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. doi: 10.1016/s0735-1097(02)01712-6.

  PMID: 11897450 BACKGROUND

Biospecimen

Retention: NONE RETAINED

blood

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Yinghui Ge, PhD

  Henan Provincial People's Hospital

  STUDY CHAIR

• You Zhang, PhD

  Henan Provincial People's Hospital

  STUDY DIRECTOR

• Shan Wang, MD

  Henan Provincial People's Hospital

  STUDY DIRECTOR

• Yi Huang, MD

  Henan Provincial People's Hospital

  STUDY DIRECTOR

• Qing Lin, MD

  Henan Provincial People's Hospital

  STUDY DIRECTOR

• Yabing Li, MD

  Henan Provincial People's Hospital

  STUDY DIRECTOR

• Lei Yu, MD

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 5, 2021
• Study Start: December 1, 2017
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

CN (1)