Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function
NCT ID: NCT05058833
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
800 participants
OBSERVATIONAL
2016-04-08
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Relationship Between Coronary Microvascular Dysfunction and Improvement of Left Ventricular Systolic Function in Patients With Heart Failure With Reduced Ejection Fraction Caused by Non-ischemic Etiology
NCT06243653
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
NCT07068633
Physiologic Assessment of Microvascular Function in Heart Transplant Patients
NCT02798731
Mitral Valve Area Using 3-dimensional Transesophageal Echocardiography
NCT01694251
Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis
NCT02608567
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
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
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
Coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Coronary flow reserve and index of microcirculatory dysfunction
Coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who underwent comprehensive physiologic assessments
* Patients who were evaluated by echocardiography
Exclusion Criteria
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chonnam National University Hospital
OTHER
Chosun University Hospital
OTHER
Gangneung Asan Hospital
OTHER
Samsung Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Joo Myung Lee
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joo Myung Lee, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Iowa Carver College of Medicine, Iowa City, IA, USA
Iowa City, Iowa, United States
Chonnam National University Hospital
Gwangju, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SMCDIAST119023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.