Prognostic Value of Angio-IMR in Hypertrophic Cardiomyopathy Patients

NCT ID: NCT06434415

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2024-07-31

Brief Summary

Coronary microvascular dysfunction (CMD) is among pathophysiological states of significance in hypertrophic cardiomyopathy (HCM). The index of microcirculatory resistance (IMR) has been recognized as an indicator of CMD and considered of important prognostic value in various conditions. The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free method to assess IMR and proved to have favourable correlation with it. This study was designed to assess prognostic impact of CMD in HCM patients, using angio-IMR as a novel non-invasive assessment tool.

Detailed Description

Coronary microvascular dysfunction (CMD) is among pathophysiological states of significance in hypertrophic cardiomyopathy (HCM). The index of microcirculatory resistance (IMR) has been recognized as an indicator of CMD and considered of important prognostic value in various conditions. The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free method to assess IMR and proved to have favourable correlation with it. In this study, patients who met the inclusion criteria were collected from two centers, and the angio-IMR of three coronary arteries was measured to monitor their microcirculation. Then, explore the prognostic value of the angio-IMR of the left anterior descending artery (LAD). At the same time combined with the sum of three coronary arteries' angio-IMR, analysis of its prognostic value. In conclusion, this study was designed to assess prognostic impact of CMD in HCM patients, using angio-IMR as a novel non-invasive assessment tool.

Conditions

Hypertrophic Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

HCM patients with low angio-IMR

This group patients have low angio-IMR value in LAD.

No interventions assigned to this group

HCM patients with high angio-IMR

This group patients have high angio-IMR value in LAD.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. diagnosed with hypertrophic cardiomyopathy(HCM) based on clinical guidelines

2. have qualified image for analysis of angio-IMR

Exclusion Criteria

1）referred to hospital due to ST-segment elevation myocardial infarction(STEMI), heart failure and cardiopulmonary arrest; 2) Implantation of any DES or DCB; 3）severe valve dysfunction; 4）history of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 5）meet the criteria of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 6）impaired life-span expectancy due to cancer or other clinical conditions；

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Jiang, MD, PhD

Role: STUDY_DIRECTOR

Second affiliated Hospital Zhejiang University School of Medicine

Other Identifiers

2024005

Identifier Type: -

Identifier Source: org_study_id