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

NCT06076551 | Recruiting

• 1 other identifier: 2017AN0358
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Microvascular Angina

Outcome Measures

Primary Outcomes (1)

• A composite outcome including all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure

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

  1 year

Interventions

Adenosine stress echocardiography DIAGNOSTIC_TEST

Transthoracic echocardiographic assessments will be performed using an ultrasound device (Vivid E95, General Electric Healthcare, Liestal, Switzerland). Color Doppler flow of the distal left anterior descending artery was examined from the modified apical four-chamber view of the anterior interventricular groove. Pulsed-wave Doppler registered blood flow velocity patterns using a sample volume (2-3.0 mm) placed on the color signal. The ultrasound beam was aligned parallel to the vessel flow. The velocity scale of color Doppler was set to 0.21 m/s. Coronary flow Doppler images were acquired at baseline and at 1, 2, and 3 min after adenosine infusion in the same part of the artery. Anti-anginal medications, including calcium channel blockers, were discontinued before the study.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• ≥ 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Seong-Mi Park, PhD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Central Study Contacts

So Ree Kim, PhD

CONTACT

82-10-9453-4810; soree8826kim@gmail.com

Study Design

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

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 11, 2023
• Study Start: February 1, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)