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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06434415
Other study ID # 2024005
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date May 31, 2024

Study information

Verified date May 2024
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 470
Est. completion date May 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. severe valve dysfunction; 3. history of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 4. meet the criteria of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 5. impaired life-span expectancy due to cancer or other clinical conditions;

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type Measure Description Time frame Safety issue
Primary MACE composite a composition of cardiac death, readmission for heart failure, and cardiac infraction within 24 months' follow-up
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