NCT05058833

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2016

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

8.7 years

First QC Date

September 17, 2021

Last Update Submit

March 12, 2025

Conditions

Ischemic Heart DiseaseMicrovascular Coronary Artery DiseaseDiastolic DysfunctionHeart Failure With Preserved Ejection Fraction

Keywords

coronary microvascular dysfunctiondiastolic dysfunctioncoronary flow reserveindex of microcirculatory resistanceprognosis

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular death

    Cardiovascular death

    3 year

Secondary Outcomes (5)

  • all-cause death

    3 year

  • Myocardial infarction

    3 year

  • Any revascularization

    3 year

  • Major adverse cardiac events

    3 year

  • Heart failure admission

    3 year

Study Arms (2)

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.

Diagnostic Test: EchocardiographyDiagnostic Test: Coronary flow reserve and index of microcirculatory dysfunction

Patients with coronary microcirculatory dysfunction

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

Diagnostic Test: EchocardiographyDiagnostic Test: Coronary flow reserve and index of microcirculatory dysfunction

Interventions

EchocardiographyDIAGNOSTIC_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.

Patients with cardiac diastolic dysfunctionPatients with coronary microcirculatory dysfunction
Coronary flow reserve and index of microcirculatory dysfunctionDIAGNOSTIC_TEST

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

Patients with cardiac diastolic dysfunctionPatients with coronary microcirculatory dysfunction

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Iowa City, Iowa, United States

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Chosun University Hospital

Gwangju, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 38538174DERIVED

  • 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.

    PMID: 36846961DERIVED

  • 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.

    PMID: 36695307DERIVED

  • 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.

    PMID: 36470507DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Joo Myung Lee, MD, MPH, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 17, 2021

First Posted

September 28, 2021

Study Start

April 8, 2016

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 14, 2025

Record last verified: 2025-03

Locations

KR(3)US(1)