Prognostic Significance of CMD Assessed by IMR in HCM Patients

NCT06190704 | Completed DMC

• 1 other identifier: caIMR-HCM
• Study Type: observational
• Target: 191
• Locations: 0 countries
• Sites: N/A

Brief Summary

The index of microcirculatory resistance (IMR) serves as an indicator of coronary microvascular dysfunction (CMD) with significant prognostic value in various clinical conditions. However, its impact on CMD in the hypertrophic cardiomyopathy (HCM), whether assessed invasively or non-invasively, is yet to be investigated. We assessed the prognostic importance of CMD using less invasive coronary angiography-derived IMR (caIMR) in HCM patients with nonobstructive epicardial coronary arteries.Patients with HCM who underwent invasive coronary angiography for suspected myocardial ischemia were included. Microvascular function was assessed using caIMR, and 460 coronary arteries were analyzed. CMD was identified with caIMR\>25U, in line with prior research, and the primary study endpoint was major adverse cardiac events (MACE).

Conditions

Coronary Cicrovascular Dysfunction; Hypertrophic Cardiomyopathy Patients

Keywords

Hypertrophic cardiomyopathy; Coronary microvascular dysfunction.; Index of microcirculatory resistance.; Prognosis

Outcome Measures

Primary Outcomes (1)

• major adverse cardiac events (MACE)

  The primary clinical endpoints in this study encompassed major adverse cardiac events (MACE), which included: 1) cardiac death: defined as events occurring in the context of cardiac decompensation, pulmonary edema, or progression to end-stage disease, along with other cardiac-related deaths; 2) non-cardiac death: defined as any death occurring during the follow-up period, irrespective of the cause; 3) cardiac readmissions: encompassing hospitalizations for heart failure, myocardial infarction, unstable angina, and malignant arrhythmias; and 4) ischemic stroke: denoting a stroke caused by a blockage in the blood flow to the brain.

  Follow-up was conducted over a mean 43-month period through telephone contact or outpatient visits.

Study Arms (2)

CMD

Microvascular function was assessed using caIMR, and 460 coronary arteries were analyzed. CMD was identified with caIMR\>25U, in line with prior research.

Device: caIMR

non-CMD

Microvascular function was assessed using caIMR, and 460 coronary arteries were analyzed. CMD was identified with caIMR≤25U, in line with prior research.

Device: caIMR

Interventions

caIMR DEVICE

Coronary angiography-derived IMR (caIMR) is a novel and accurate alternative that can enable the assessment of coronary microvascular function easier, and more efficiently and does not require pressure wire or adenosine.

CMD; non-CMD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with HCM and referred to the catheterization lab at Shanghai Tenth People's Hospital between 2014 and 2023 for invasive coronary angiography (CAG) due to suspected myocardial ischemia were included in this single-center retrospective observational study

You may qualify if:

• Age \>18 years old;
• echocardiographic evidence of HCM, defined as LV myocardial wall thickness of ≥15 mm and or a LV myocardial wall thickness of ≥13 mm in individuals with a family history of HCM, in the absence of an alternative cause for LV hypertrophy

You may not qualify if:

• significant mitral regurgitation;
• second and third-degree atrioventricular block;
• presence of significant epicardial coronary stenosis (≥50% stenosis) on CAG;
• poor life expectancy resulting from concurrent health disease.;
• reduced contrast opacification (for caIMR assessment)

Sponsors & Collaborators

• Ya-Wei Xu: lead

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: September 13, 2014
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share