Prognostic Value of Angio-IMR in Hypertrophic Cardiomyopathy Patients

Active, not recruiting

• Conditions: Hypertrophic Cardiomyopathy

• Registration Number: NCT06434415
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2024-01-31
• Status Verified: 2024-05
• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-23
• Study First Posted: 2024-05-30
• Study Completion: 2024-07-31
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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；

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE composite	within 24 months' follow-up	a composition of death from cardiovascular causes, progression to severe functional limitation (NYHA class III or IV), and sustained, life-threatening ventricular arrhythmias requiring the implantation of a cardioverter-defibrillator,septal myocardial ablation or septal myectomy, new on stroke.