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

NCT07422818 | Not Yet Recruiting

• 1 other identifier: 7363
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

ANOCA - Angina With Non-obstructive Coronary Arteries

Outcome Measures

Primary Outcomes (1)

• Correlation (Phi coefficient) between TTE-induced vasoconstriction and acetylcholine-induced spasm at invasive assessment.

  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 coronary vasomotor disturbance.

  Periprocedural

Secondary Outcomes (3)

• Agreement between dipyridamole-induced non-invasive coronary flow reserve and invasive coronary flow reserve

  Periprocedural

• Agreement between cold pressor test-induced non-invasive coronary flow reserve and invasive coronary flow reserve

  Periprocedural

• Association between abnormal non-invasive coronary vasomotor response and angina symptoms

  Periprocedural

Study Arms (2)

Non-invasive coronary flow reserve in patients with ANOCA

EXPERIMENTAL

We will enroll patients referred to the catheterization laboratory of the Fondazione Policlinico Universitario A. Gemelli IRCCS for stable angina who showed non-obstructive coronary arteries at coronary angiography and underwent invasive coronary functional tests (adenosine and/or acetylcholine test).

Diagnostic Test: Coronary flow reserve assessed by Echocardiography

Non-invasive coronary flow reserve in healthy volunteers

ACTIVE COMPARATOR

To confirm the reliability of possible abnormal results of non-invasive coronary functional tests in angina and non-obstructive coronary arteries (ANOCA) patients, we will enroll healthy control subjects of similar age and gender of enrolled patients, selected among those referred to our ambulatory of clinical visits for a routine cardiological evaluation and undergo a screening stress test for coronary artery disease. They will undergo a dipyridamole stress echocardiogram, which is commonly used in clinical practice to investigate the presence of coronary artery disease.

Diagnostic Test: Coronary flow reserve assessed by Echocardiography

Interventions

Coronary flow reserve assessed by Echocardiography DIAGNOSTIC_TEST

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.

Non-invasive coronary flow reserve in healthy volunteers; Non-invasive coronary flow reserve in patients with ANOCA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 90 years;
• ICA performed within the previous 12 months from enrollment and characterized by: (a) absence of obstructive CAD (\<50% diameter reduction or FFR by \>0.80); (b) invasive assessment of epicardial/microvascular spasm by acetylcholine test;
• Signed informed consent.

You may not qualify if:

• Presentation as an acute coronary syndrome (i.e. unstable chest pain) or a typical history of variant angina (frequent angina pain at rest with ST-segment elevation at the ECG, caused by recurrent coronary spasm);
• Previous coronary revascularization with surgical intervention;
• Asthma or known intolerance or contraindications to dipyridamole;
• Serious medical conditions, including renal failure (eGFR \<30 mL/min), liver diseases, malignancies, and acute or chronic inflammatory diseases;
• Pregnancy;
• Psychological conditions that might hamper patient co-operation;
• Any condition that, in the judgment of the investigators, would make difficult for the patient to complete the study protocol;
• Missed informed consent.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-01