NCT07422818

Non-invasive Evaluation of Patients With Angina and Non-obstructive Coronary Artery Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, prospective interventional study evaluating noninvasive coronary function testing using transthoracic Doppler echocardiography of the left anterior descending coronary artery in patients with stable angina and nonobstructive coronary artery disease (ANOCA) who previously underwent invasive coronary function testing (adenosine and/or acetylcholine). A group of age- and sex-matched healthy volunteers will be enrolled to support interpretation of potentially abnormal noninvasive responses observed in patients.

Detailed description

Patients referred to the catheterization laboratory of Fondazione Policlinico Universitario A. Gemelli IRCCS for stable angina who show non-obstructive coronary artery disease at invasive coronary angiography and underwent invasive coronary function testing will be enrolled. During a transthoracic echocardiographic Doppler examination of the left anterior descending coronary artery, participants will undergo three standardized stimuli (hyperventilation, cold pressor test, and dipyridamole) separated by 30-minute intervals, with peak diastolic velocity measured at baseline and at the end of each test. For each stimulus, the coronary blood flow velocity response will be expressed as the ratio between peak and basal peak diastolic velocity. Participants will also complete the Seattle Angina Questionnaire to assess symptom burden. The primary aim of the study is to investigate the usefulness of studying coronary flow reserve by transthoracic color Doppler echocardiogram in reaching the diagnosis of microcirculation dysfunction and/or coronary vasomotor disturbance. The secondary aim of the study was to assess whether abnormalities on the stress echocardiogram with dipyridamole, hyperventilation, and cold-pressor test are related to the patient's symptoms.

Conditions

• ANOCA - Angina With Non-obstructive Coronary Arteries

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Coronary flow reserve assessed by Echocardiography	All patients and controls will undergo the following tests during transthoracic echocardiographic Doppler examination of the left anterior descending coronary artery, with time intervals of 30 minutes from each other: 1. hyperventilation test: the patient is asked to breathe at a rate of 30 respirations per minute, for 5 minutes; 2. cold pressor test: the patient puts his/her right hand in ice water for 2 minutes; 3. dipyridamole test: intravenous dipyridamole is administered at a dose of 0.84 mg/kg over 6 minutes; Peak diastolic velocity (PDV) of blood flow in the left anterior descending coronary artery will be measured before and at the end of each test by pulsed-wave Doppler, using a GE E95 echocardiographic machine. The ratio between peak flow velocity of coronary blood flow at peak of each test and the relative basal peak flow velocity of coronary blood flow is taken as the response of coronary blood flow velocity to each test.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2026-02-20
• Last updated: 2026-02-20