Sex Difference of Coronary Microvascular Dysfunction in Patients With Non-obstructive Coronary Artery Disease

Sponsor

Korea University Anam Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06076551

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sex difference of coronary microvascular dysfunction evaluated by coronary flow reserve will be assessed in patients with non-obstructive coronary artery disease

Condition or Disease	Intervention/Treatment	Phase
Microvascular Angina	Diagnostic Test: Adenosine stress echocardiography

Detailed Description

The investigators will select consecutive patients who experienced chest pain but had no significant coronary artery stenosis (<50% stenosis). Coronary microvascular function will be evaluated by adenosine stress echocardiography. Coronary blood flow velocities will be measured at 1, 2, and 3 min after adenosine infusion.

Sex difference of coronary microvascular dysfunction evaluated by coronary flow reserve will be assessed.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Sex Difference of Coronary Microvascular Dysfunction Evaluated by Coronary Flow Reserve in Patients With Non-obstructive Coronary Artery Disease

Actual Study Start Date :

Feb 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

A composite outcome including all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure [1 year]
Number of participants with a composite outcome including all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Typical/atypical chest pain or ischemic symptoms including dyspnea
No significant coronary artery stenosis (<50% stenosis) in coronary angiography or computed tomography

Exclusion Criteria:

≥ Moderate valvular heart disease
Congenital heart disease
Chronic renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2) or end-stage renal failure undergoing hemodialysis or peritoneal dialysis
Asthma, chronic obstructive pulmonary disease and primary pulmonary hypertension
Receiving anticancer drugs
Vasculitis associated with autoimmune diseases
Atrioventricular block with more than second degrees, symptomatic bradycardia, cryo-node failure syndrome, Wolff-Parkinson-White (WPW) patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Anam Hospital	Seoul		Korea, Republic of	02841

Sponsors and Collaborators

Korea University Anam Hospital

Investigators

Principal Investigator: Seong-Mi Park, PhD, Korea University Anam Hospital
Study Chair: Mi-Na Kim, PhD, Korea University Anam Hospital
Study Chair: Dong-Hyuk Cho, PhD, Korea University Anam Hospital
Study Chair: So Ree Kim, PhD, Korea University Anam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seong-Mi Park, M.D. Ph.D., Professor, Korea University Anam Hospital

ClinicalTrials.gov Identifier:

NCT06076551

Other Study ID Numbers:

2017AN0358

First Posted:

Oct 11, 2023

Last Update Posted:

Oct 13, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Oct 13, 2023