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

August 16, 2022 updated by: Henan Provincial People's Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Excessive tortuosity of the coronary arteries (TCA) is a somewhat common finding in patients referred for coronary angiography, reported in 14-40% of patients referred for angiography. The presence of TCA has been associated with chest pain and myocardial perfusion abnormalities during stress in the absence of obstructive coronary artery disease. Fluid dynamic modeling suggests that stress-induced ischemia may be attributable to a reduction in distal coronary artery perfusion pressure from viscous and turbulence energy losses. The physiologic reasons for TCA are unclear. The roles of TCA on prognosis of HCM are also needed to explore. Pre-clinical studies where elastases and collagenases were used to alter arterial morphology together with genetic and pathologic analysis of rare clinical disorders such as arterial tortuosity syndrome have indicated that arterial tortuosity arises from abnormalities in arterial elastin fibers and extracellular matrix. Apart from inherited disorders, some but not all studies have linked TCA with hypertension and female sex, and with increased left ventricular (LV) mass from pressure but not volume overload and smaller heart size.

Hypertrophic cardiomyopathy (HCM) is associated with an increased left ventricular (LV) wall thickness. HCM is the most common genetic heart disease, characterized by marked clinical and morphologic heterogeneity. Diagnosis is usually based on the echocardiographic finding of unexplained left ventricular (LV) hypertrophy, defined by increased wall thickness in 1 or more LV segments. LV mass is generally assumed to be increased in patients with phenotypically expressed HCM, based largely on early pathological studies. TCA among HCM patients have not been studied. So, firstly, we choose HCM and non-HCM patients to investigate the relationship between TCA and HCM, and further explore the potential roles of TCA for prognosis in HCM.

In HCM patients, disruption of the ordered arrangement of myofibers alters normal cardiac mechanical function, resulting in temporal and spatial heterogeneity in regional myocardial contractility. Although global LV function is generally unaltered, asynchrony and asynergy in regional function lead to delayed diastolic relaxation and impaired diastolic filling. Whilst LV ejection fraction is frequently normal in both, LV strain assessment could differentiate, compared to normal person. Cardiovascular magnetic resonance (CMR), by virtue of its high-resolution volumetric reconstruction of the LV chamber, currently affords a highly accurate and reproducible quantitative assessment of mass . So secondly, we sought to establish if cardiovascular magnetic resonance myocardial feature tracking (CMR-FT), an emerging method allowing accurate assessment of myocardial deformation, differentiates between HCM with or without TCA. Additionally, we want to explore the potential genetic factor on TCA in HCM.

This is a single-center, retrospective, case control study that will evaluate the difference of TCA between HCM and non-HCM, and explore the prognostic roles of TCA in the first part. In the second part, we will use CMR-FT to compare the myocardial strain between HCM with or without TCA and analyze the relationship of strain and TCA. In the third part, we choose HCM patients and non-HCM to investigate potential genetic factors for TCA in HCM.

Study Type

Observational

Enrollment (Actual)

302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Central China Fuwai Hospital, Heart Center of Henan Provincal People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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）

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hypertrophic cardiomyopathy
patients with hypertrophic cardiomyopathy
Other: no intervention
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.
control without hypertrophic cardiomyopathy
controls without hypertrophic cardiomyopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
coronary artery tortuosity and tortuosity score in hypertrophic cardiomyopathy patients
Time Frame: six months
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
Time Frame: 2017/12/01-2022/07/01
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
Time Frame: 2017/12/01-2022/07/01
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial strain and strain rate in hypertrophic cardiomyopathy patients with coronary artery tortuosity
Time Frame: six months
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
genetic factors(such as genetic mutation site for HCM(MYBPC3,MYH7,ACTC1,TNNI3)) for hypertrophic cardiomyopathy patients with coronary artery tortuosity
Time Frame: two months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Provincial People's Hospital

Investigators

  • Study Chair: Yinghui Ge, PhD, Henan Provincial People's Hospital
  • Study Director: 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
  • Principal Investigator: Lei Yu, MD, Henan Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

July 1, 2022

Study Completion (ACTUAL)

August 1, 2022

Study Registration Dates

First Submitted

March 28, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (ACTUAL)

April 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCAHCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It will be decided by patients , hospital and Chinese health authority.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertrophic Cardiomyopathy

Clinical Trials on no intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe