Clinical trial NCT05671367: Association Between Microvascular Resistance and Outcomes in Patients With Obstructive Hypertrophic Cardiomyopathy
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microvascular Dysfunction
Hypertrophic Obstructive Cardiomyopathy
Microcirculation Resistance
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-01-04
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From January 2017 to November 2021, patients with hypertrophic obstructive cardiomyopathy underwent coronary angiography in Fuwai Hospital.

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.


Eligibility criteria: 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;

Primary outcomes:
measure: The Major Adverse Cardiovascular Events related to HoCM
timeFrame: One-year followed up after angiography
Secondary outcomes:
measure: Scale of KCCQ-12
timeFrame: One-year followed up after angiography
measure: Borg Index after 6MWT
timeFrame: One-year followed up after angiography
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, China National Center for Cardiovascular Diseases
state: Beijing
Study officials:
affiliation: Fuwai Hospital, China National Center for Cardiovascular Diseases
name: Lihong Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Authors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.
citation: Maron BJ, Maron MS. Hypertrophic cardiomyopathy. Lancet. 2013 Jan 19;381(9862):242-55. doi: 10.1016/S0140-6736(12)60397-3. Epub 2012 Aug 6.
citation: Stahli BE, Erbay A, Steiner J, Klotsche J, Mochmann HC, Skurk C, Lauten A, Landmesser U, Leistner DM. Comparison of resting distal to aortic coronary pressure with angiography-based quantitative flow ratio. Int J Cardiol. 2019 Mar 15;279:12-17. doi: 10.1016/j.ijcard.2018.11.093. Epub 2018 Nov 17.
citation: Park J, Lee JM, Koo BK, Shin ES, Nam CW, Doh JH, Hwang D, Zhang J, Hu X, Wang J, Ye F, Chen S, Yang J, Chen J, Tanaka N, Yokoi H, Matsuo H, Takashima H, Shiono Y, Akasaka T. Clinical Relevance of Functionally Insignificant Moderate Coronary Artery Stenosis Assessed by 3-Vessel Fractional Flow Reserve Measurement. J Am Heart Assoc. 2018 Feb 15;7(4):e008055. doi: 10.1161/JAHA.117.008055.
citation: Fan Y, Fezzi S, Sun P, Ding N, Li X, Hu X, Wang S, Wijns W, Lu Z, Tu S. In Vivo Validation of a Novel Computational Approach to Assess Microcirculatory Resistance Based on a Single Angiographic View. J Pers Med. 2022 Oct 31;12(11):1798. doi: 10.3390/jpm12111798.