Prognostic Value of Angio-IMR in Hypertrophic Cardiomyopathy Patients

NCT06434415 | Active Not Recruiting

• 1 other identifier: 2024005
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• MACE composite

  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.

  within 24 months' follow-up

Study Arms (2)

HCM patients with low angio-IMR

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

HCM patients with high angio-IMR

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We retrospectively enrolled patients who were diagnosed with hypertrophic cardiomyopathy(HCM) and underwent invasive coronary angiography between 2017 and 2024 at two sites (The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China; Ningbo Medical Center Lihuili Hospital, Ningbo, China) .The diagnosis of HCM was based on current clinical guidelines.

You may qualify if:

• diagnosed with hypertrophic cardiomyopathy(HCM) based on clinical guidelines
• have qualified image for analysis of angio-IMR

You may not qualify if:

• ）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；

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Ningbo Medical Center Lihuili Hospital: collaborator

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

• Jun Jiang, MD, PhD

  Second affiliated Hospital Zhejiang University School of Medicine

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: January 1, 2017
• Primary Completion: January 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-05