Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function

NCT ID: NCT05058833

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-08

Study Completion Date

2024-12-31

Brief Summary

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The DIAST-CMD registry (Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function) is prospective registry which enrolled patients who underwent echocardiography, cnically-indicated invasive coronary angiography and comprehensive physiologic assessments including fractional flow reserve (FFR), CFR, and IMR measurements for at least 1 vessel from Samsung Medical Center. Patients with hemodynamic instability, severe LV dysfunction (left ventricular ejection fraction\<40%), a culprit vessel of acute coronary syndrome, severe valvular stenosis or regurgitation were excluded.

Detailed Description

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Cardiac diastolic dysfunction refers to a condition in which abnormalities in mechanical function are present during diastole and is an independent predictor of mortality, even in patients with preserved left ventricular (LV) systolic function. Clinical manifestations of cardiac diastolic dysfunction are also variable, from asymptomatic subclinical heart failure to heart failure with preserved ejection fraction, angina or exercise intolerance without significant epicardial coronary artery disease, or end-stage heart failure. Although its pathophysiology remains incompletely understood, findings from clinical and pre-clinical studies have suggested systemic endothelial dysfunction, oxidative stress, and coronary microvascular dysfunction (CMD) could be important pathophysiologic mechanisms for cardiac diastolic dysfunction.

In this regard, recent studies evaluated non-invasively measured coronary flow reserve (CFR) from positron emission tomography (PET), cardiac magnetic resonance imaging (MRI), or Doppler echocardiography, and presented the association of depressed global CFR with cardiac diastolic dysfunction and higher risk of clinical events. The presence of CMD can be also evaluated by invasive physiologic assessment using both CFR and index of microcirculatory resistance (IMR). Previous studies presented CMD could be one of the major causes of angina without significant epicardial coronary artery disease and an independent predictor of adverse clinical events in patients with stable ischemic heart disease, acute myocardial infarction (MI), or myocardial disease. Nevertheless, there has been limited study which evaluated the association between cardiac diastolic dysfunction and CMD using invasive physiologic indices and their prognostic implications, especially in non-MI patients without significant coronary artery stenosis.

Therefore, the current study was designed the current DIAST-CMD registry to evaluate 3 important clinical questions as to whether: (1) cardiac diastolic dysfunction is significantly associated with the presence of CMD; 2) both cardiac diastolic dysfunction and CMD are significantly associated with long-term cardiovascular death; and 3) integration of both disease entities would have incremental prognostic stratification in non-MI patients without significant epicardial coronary artery disease.

Conditions

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Ischemic Heart Disease Microvascular Coronary Artery Disease Diastolic Dysfunction Heart Failure With Preserved Ejection Fraction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with cardiac diastolic dysfunction

Echocardiographic grades of diastolic function was defined according to 2016 ASE/EACVI recommendations for the evaluation of LV diastolic function. Cardiac diastolic dysfunction was defined as elevated E/e'≥15.

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Echocardiographic grades of diastolic function was defined according to 2016 ASE/EACVI recommendations for the evaluation of LV diastolic function. Cardiac diastolic dysfunction was defined as elevated E/e'≥15.

Coronary flow reserve and index of microcirculatory dysfunction

Intervention Type DIAGNOSTIC_TEST

Coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).

Patients with coronary microcirculatory dysfunction

Patients with coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Echocardiographic grades of diastolic function was defined according to 2016 ASE/EACVI recommendations for the evaluation of LV diastolic function. Cardiac diastolic dysfunction was defined as elevated E/e'≥15.

Coronary flow reserve and index of microcirculatory dysfunction

Intervention Type DIAGNOSTIC_TEST

Coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).

Interventions

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Echocardiography

Echocardiographic grades of diastolic function was defined according to 2016 ASE/EACVI recommendations for the evaluation of LV diastolic function. Cardiac diastolic dysfunction was defined as elevated E/e'≥15.

Intervention Type DIAGNOSTIC_TEST

Coronary flow reserve and index of microcirculatory dysfunction

Coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent clinically-indicated invasive coronary angiography
* Patients who underwent comprehensive physiologic assessments
* Patients who were evaluated by echocardiography

Exclusion Criteria

* Patients with unavailable echocardiography data
* Patients with hemodynamic instability
* Patients with severe LV dysfunction (LV ejection fraction\<30%)
* Patients with severe valvular stenosis or regurgitation
* Culprit vessel of acute coronary syndrome
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chonnam National University Hospital

OTHER

Sponsor Role collaborator

Chosun University Hospital

OTHER

Sponsor Role collaborator

Gangneung Asan Hospital

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Joo Myung Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joo Myung Lee, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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University of Iowa Carver College of Medicine, Iowa City, IA, USA

Iowa City, Iowa, United States

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Chosun University Hospital

Gwangju, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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United States South Korea

References

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Lee SH, Choi KH, Hong D, Shin D, Joh HS, Kim HK, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Prognostic Implications of Microvascular Resistance Reserve in Symptomatic Patients With Intermediate Coronary Stenosis. JACC Cardiovasc Interv. 2024 Mar 25;17(6):786-797. doi: 10.1016/j.jcin.2024.01.008.

Reference Type DERIVED
PMID: 38538174 (View on PubMed)

Hong D, Shin D, Lee SH, Joh HS, Choi KH, Kim HK, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Prognostic Impact of Coronary Microvascular Dysfunction According to Different Patterns by Invasive Physiologic Indexes in Symptomatic Patients With Intermediate Coronary Stenosis. Circ Cardiovasc Interv. 2023 Mar;16(3):e012621. doi: 10.1161/CIRCINTERVENTIONS.122.012621. Epub 2023 Feb 27.

Reference Type DERIVED
PMID: 36846961 (View on PubMed)

Hong D, Lee SH, Shin D, Choi KH, Kim HK, Ha SJ, Joh HS, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function on Cardiovascular Death. J Am Heart Assoc. 2023 Feb 7;12(3):e027690. doi: 10.1161/JAHA.122.027690. Epub 2023 Jan 25.

Reference Type DERIVED
PMID: 36695307 (View on PubMed)

Chung YJ, Choi KH, Lee SH, Shin D, Hong D, Park S, Joh HS, Kim HK, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Prognostic Impact of Indeterminate Diastolic Function in Patients With Functionally Insignificant Coronary Stenosis. J Am Soc Echocardiogr. 2023 Mar;36(3):295-306.e5. doi: 10.1016/j.echo.2022.11.014. Epub 2022 Dec 5.

Reference Type DERIVED
PMID: 36470507 (View on PubMed)

Other Identifiers

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SMCDIAST119023

Identifier Type: -

Identifier Source: org_study_id

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