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

NCT ID: NCT05671367

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 340 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2022-11-01

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.

Conditions

Microvascular Dysfunction; Hypertrophic Obstructive Cardiomyopathy; Microcirculation Resistance

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

No interventions assigned to this group

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Lihong Ma

Director of Department of Traditional Chinese Medicine, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lihong Ma, MD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, China National Center for Cardiovascular Diseases

Locations

Fuwai Hospital, China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 25173338 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22874472 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 30545620 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29449274 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36573725 (View on PubMed)

Other Identifiers

2022-1872

Identifier Type: -

Identifier Source: org_study_id