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NCT Number: NCT06076551

Sex Difference of Coronary Microvascular Dysfunction 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

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location status: Recruiting

Location contact

Dong-Hyuk Cho

SUB_INVESTIGATOR

Mi-Na Kim

SUB_INVESTIGATOR

Seong-Mi Park

PRINCIPAL_INVESTIGATOR

So Ree Kim

SUB_INVESTIGATOR

So Ree Kim, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

So Ree Kim, PhD

CONTACT

[email protected]

82-10-9453-4810

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Oct 11, 2023
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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