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

Microvascular Angina Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076551
• Other study ID #: 2017AN0358
• Status: Recruiting
• Start date: February 1, 2018
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Korea University Anam Hospital
• Contact: So Ree Kim, PhD
• Phone: 82-10-9453-4810
• Email: soree8826kim[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Microvascular Angina
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Adenosine stress echocardiography
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 ?ow velocity patterns using a sample volume (2-3.0 mm) placed on the color signal. The ultrasound beam was aligned parallel to the vessel ?ow. The velocity scale of color Doppler was set to 0.21 m/s. Coronary ?ow 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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