CompletedNCT05671367Updated Jan 13, 2023

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

An observational study in Microvascular Dysfunction, Hypertrophic Obstructive Cardiomyopathy and Microcirculation Resistance, sponsored by China National Center for Cardiovascular Diseases. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-13.

Sponsored by China National Center for Cardiovascular Diseases · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 340
Ages: 18 Years to 80 Years
Sex: All

Study 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 studied

Microvascular Dysfunction
Hypertrophic Obstructive Cardiomyopathy
Microcirculation Resistance

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In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 340 is above the median of 153 across 515 observational studies indexed under Cardiomyopathies.

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Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

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

Inclusion criteria

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;

Exclusion criteria

Exclusion criteria:

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 340 participants (actual)
Patient registry: No

Groups and cohorts

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 researchers measure

Primary outcomes

The Major Adverse Cardiovascular Events related to HoCM
including all-cause death, heart transplantation, left ventricular pacemaker, heart failure readmission
Time frame: One-year followed up after angiography

Secondary outcomes

Scale of KCCQ-12
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.
Time frame: One-year followed up after angiography
Borg Index after 6MWT
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.
Time frame: One-year followed up after angiography

Study locations

1 site

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

References and documents

Publications

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. PubMed 25173338 ↗
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. PubMed 22874472 ↗
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. PubMed 30545620 ↗
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. PubMed 29449274 ↗
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. PubMed 36573725 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05671367
Lead sponsor: China National Center for Cardiovascular Diseases
Responsible party: Lihong Ma (Director of Department of Traditional Chinese Medicine, Principal Investigator, Clinical Professor, China National Center for Cardiovascular Diseases) — Principal investigator
First posted: Jan 4, 2023
Start date: Jan 1, 2017
Primary completion: Nov 1, 2021
Completion: Nov 1, 2022
Last update: Jan 13, 2023

Study contacts

Lihong Ma, MD

principal investigator · Fuwai Hospital, China National Center for Cardiovascular Diseases

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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