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

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.

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Key information

Conditions

Microvascular Dysfunction Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hypertrophic Obstructive Cardiomyopathy Microcirculation Resistance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 18-80 years old;
Patients with hypertrophic obstructive cardiomyopathy undergoing coronary angiography. Diagnosis criteria that meet the diagnostic guidelines for hypertrophic obstructive cardiomyopathy: It usually refers to the thickness of the ventricular septum or left ventricular wall measured by two-dimensional echocardiography > 15 mm, or the thickness of > 13mm in patients with a clear family history, usually without enlargement of the left ventricular cavity, and the thickening of the left ventricular wall caused by increased loads, such as hypertension, aortic stenosis, and congenital subvalvular septum should be excluded; LVOTG>30 mmHg under quiet or exercise conditions.
The informed consent form for the use of sample data of patients admitted to the hospital has been signed;

Exclusion criteria

No contrast examination is performed for various reasons;
Missing baseline important information indicators;
Loss of follow-up;

Treatment and study plan

Primary outcomes

The Major Adverse Cardiovascular Events related to HoCM

Time frame: One-year followed up after angiography

including all-cause death, heart transplantation, left ventricular pacemaker, heart failure readmission

Secondary outcomes

Scale of KCCQ-12

Time frame: 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.
Borg Index after 6MWT

Time frame: 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.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Evaluation of the Correlation Between Coronary Microvascular Resistance Based on Quantitative Flow Ratio and Major Adverse Cardiovascular Events in Patients With Obstructive Hypertrophic Cardiomyopathy: A Retrospective Cohort Study

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2022
First posted: Jan 4, 2023
Registry last updated: Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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