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

October 11, 2023 updated by: Seong-Mi Park, M.D. Ph.D., Korea University Anam Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Principal Investigator:
          • Seong-Mi Park
        • Sub-Investigator:
          • Mi-Na Kim
        • Sub-Investigator:
          • So Ree Kim
        • Contact:
        • Sub-Investigator:
          • Dong-Hyuk Cho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive patients who experienced chest pain but with no obstructed coronary arteries (<50% stenosis)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A composite outcome including all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure
Time Frame: 1 year
Number of participants with a composite outcome including all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017AN0358

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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