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

January 11, 2023 updated by: Lihong Ma, China National Center for Cardiovascular Diseases

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Fuwai Hospital, China National Center for Cardiovascular Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

From January 2017 to November 2021, patients with hypertrophic obstructive cardiomyopathy underwent coronary angiography in Fuwai Hospital.

Description

Inclusion criteria:

  1. Aged 18-80 years old;
  2. 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.
  3. The informed consent form for the use of sample data of patients admitted to the hospital has been signed;

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Artery without microcirculation resistance
The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR<2.5 mmHg*s/cm is defined as no microvascular resistance.
Single artery with microcirculation resistance
The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR≥2.5 mmHg*s/cm is defined as microvascular resistance. There is only one of three major coronary arteries in 3 that meets this condition.
Multiple arteries with microcirculation resistance
The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR≥2.5 mmHg*s/cm is defined as microvascular resistance. Two of the three major coronary arteries meet this condition.
Three arteries with microcirculation resistance
The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR≥2.5 mmHg*s/cm is defined as microvascular resistance. All three major coronary arteries meet this condition.
Significant microcirculation resistance
The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR≥2.5 mmHg*s/cm is defined as microvascular resistance. The sum of AMR of the three main arteries is greater than 7.5mmHg*s/cm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One-year followed up after angiography

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One-year followed up after angiography
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.
One-year followed up after angiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Principal Investigator: Lihong Ma, MD, Fuwai Hospital, China National Center for Cardiovascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

December 31, 2022

First Submitted That Met QC Criteria

December 31, 2022

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1872

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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