Association Between Microvascular Resistance and Outcomes in Patients With Obstructive Hypertrophic Cardiomyopathy

Completed

• Conditions: Microcirculation Resistance; Hypertrophic Obstructive Cardiomyopathy; Microvascular Dysfunction

• Registration Number: NCT05671367
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

About 60% of patients with hypertrophic cardiomyopathy have microvascular dysfunction. Microvascular dysfunction is directly related to prognosis in hypertrophic cardiomyopathy. This new measurement method is microcirculation resistance (MR) based on quantitative flow ratio (QFR), which does not need a pressure guide wire on the basis of angiography. The QFR system is used to evaluate the blood vessels distal pressure and blood flow, and their ratio is microcirculation resistance (MR). The quantitative blood flow fraction measurement system was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). This study is a single-center retrospective cohort study. Participants were selected from patients who were diagnosed with hypertrophic obstructive cardiomyopathy in Fuwai Hospital from January 2020 to November 2021. The risk factor is whether there is microcirculation resistance disorder. The outcome was the major adverse cardiovascular events related to HCM (including all-cause death, heart transplantation, left ventricular pacemaker, and heart failure readmission) that were followed up one year after angiography. Aim To further clarify whether there is a certain correlation between microvascular resistance and adverse cardiovascular prognosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2021-11-01
• Study Completion: 2022-11-01
• Study First Submitted: 2022-12-31
• Study First Submitted QC: 2022-12-31
• Status Verified: 2023-01
• Study First Posted: 2023-01-04
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Major Adverse Cardiovascular Events related to HoCM	One-year followed up after angiography	including all-cause death, heart transplantation, left ventricular pacemaker, heart failure readmission

Secondary Outcome Measures

Name	Time	Method
Borg Index after 6MWT	One-year followed up after angiography	Borg index reflects the dyspnea and fatigue level after 6MWT, with a standard score of 0-10. The score ranged from 0 to 10 points, and a higher score indicated a better prognosis.
Scale of KCCQ-12	One-year followed up after angiography	KCCQ-12, a questionnaire of cardiomyopathy in Kansas City, which comes from the telephone follow-up or reexamination of cardiac rehabilitation records of departments, consists of 8 questions and 12 items, which are simplified from KCCQ-23. The score ranged from 0 to 100 points, with a higher score and better health.

Trial Locations

Locations (1)

Fuwai Hospital, China National Center for Cardiovascular Diseases; 🇨🇳 Beijing, Beijing, China