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

NCT05671367 | Completed DMC

• 1 other identifier: 2022-1872
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The Major Adverse Cardiovascular Events related to HoCM

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

  One-year followed up after angiography

Secondary Outcomes (2)

• Scale of KCCQ-12

  One-year followed up after angiography

• Borg Index after 6MWT

  One-year followed up after angiography

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (5)

• 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.

  PMID: 25173338 BACKGROUND

• 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.

  PMID: 22874472 BACKGROUND

• 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.

  PMID: 30545620 BACKGROUND

• 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.

  PMID: 29449274 BACKGROUND

• 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.

  PMID: 36573725 BACKGROUND

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 Officials

• Lihong Ma, MD

  Fuwai Hospital, China National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Traditional Chinese Medicine, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 31, 2022
• First Posted: January 4, 2023
• Study Start: January 1, 2017
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

CN (1)