Non-Invasive Coronary Functional Evaluation of Patients With Single-vessel Coronary Artery Disease

NCT07805187 | Not Yet Recruiting

• 1 other identifier: 26956
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Persistent or recurrent angina after successful percutaneous coronary intervention (PCI) remains a common clinical problem, affecting approximately 20-30% of patients despite complete epicardial coronary revascularization. Coronary microvascular dysfunction (CMD) has been proposed as a potential mechanism underlying persistent symptoms and abnormal functional testing after PCI, but it is still unclear whether CMD develops as a consequence of the PCI procedure or represents a pre-existing condition associated with coronary artery disease. The NICE-CAD-PCI study is a prospective, single-center study designed to investigate coronary microvascular function in patients with stable single-vessel coronary artery disease treated with PCI. Specifically, the study will compare coronary microvascular function in the left anterior descending coronary artery (LAD) territory between patients undergoing PCI of the LAD and patients undergoing PCI of a different coronary artery (right coronary artery or left circumflex artery). This approach aims to clarify whether impaired coronary microvascular function is limited to the treated vascular territory, suggesting a PCI-related effect, or is also present in non-treated territories, supporting the hypothesis of a pre-existing generalized microvascular abnormality. Within four weeks after PCI, all participants will undergo a comprehensive non-invasive coronary functional evaluation using transthoracic Doppler echocardiography (TTDE) to assess coronary blood flow velocity in the LAD during hyperventilation, cold pressor, and dipyridamole stress tests. Coronary flow reserve and coronary flow responses to the different physiological stimuli will be evaluated as markers of coronary vascular function. Participants will be followed for six months after PCI to assess the occurrence of clinically driven target lesion revascularization and major adverse cardiovascular events. The study will also explore whether abnormalities detected by non-invasive coronary functional testing are associated with restenosis or adverse clinical outcomes. The findings of this study may improve the understanding of the mechanisms responsible for persistent symptoms after PCI and contribute to the identification of patients with coronary microvascular dysfunction who may benefit from tailored diagnostic and therapeutic strategies.

Conditions

PCI Patients; Single Coronary Vessel Disease

Outcome Measures

Primary Outcomes (1)

• Difference in coronary flow reserve (CFR) between the LAD and non-LAD groups

  Coronary flow reserve (CFR) will be measured by transthoracic Doppler echocardiography (TTDE) in the left anterior descending coronary artery during dipyridamole administration. CFR will be calculated as the ratio between peak hyperemic and baseline diastolic coronary blood flow velocity. Mean CFR values will be compared between patients undergoing PCI of the LAD (LAD group) and patients undergoing PCI of a non-LAD coronary artery (non-LAD group). CFR is a dimensionless ratio.

  Duration of the procedure

Secondary Outcomes (1)

• Incidence of major adverse cardiovascular events (MACE) according to the presence of functional coronary abnormalities

  6-months after the enrollment.

Study Arms (2)

LAD group

OTHER

Patients with stable single-vessel coronary artery disease who underwent successful percutaneous coronary intervention (PCI) of the left anterior descending coronary artery. All participants undergo non-invasive coronary functional assessment by transthoracic Doppler echocardiography within 4 weeks after PCI and 6-month clinical follow-up.

Diagnostic Test: Coronary flow reserve assessed by Echocardiography

Non-LAD group

OTHER

Patients with stable single-vessel coronary artery disease who underwent successful percutaneous coronary intervention (PCI) of the right coronary artery or left circumflex artery. All participants undergo non-invasive coronary functional assessment by transthoracic Doppler echocardiography within 4 weeks after PCI and 6-month clinical follow-up.

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 15 minutes from each other: a) hyperventilation test: the patient is asked to breathe at a rate of 30 respirations per minute, for 5 minutes; b) cold pressor test: the patient puts his/her right hand in ice water for 2 minutes; c) 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.

LAD group; Non-LAD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Invasive coronary angiography and PCI performed within the previous 4 weeks from enrollment;
• Obstructive single-vessel CAD (\>75% coronary diameter reduction or fractional flow reserve \<0.80) treated with PCI.

You may not qualify if:

• Presentation as an acute coronary syndrome (i.e. unstable angina or myocardial infarction) 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 history of specific heart disease, e.g., ischemic (previous percutaneous or surgical myocardial revascularization, myocardial infarction), valvular, congenital heart disease or cardiomyopathy;
• Multivessel coronary artery disease;
• Serious medical conditions, including renal failure (eGFR \<30 mL/min), liver diseases, malignancies, and acute or chronic inflammatory diseases;
• Contraindication to dipyridamole;
• Pregnancy;
• Psychological conditions that might interfere with patient co-operation;
• Any condition that, in the judgment of the investigators, would make difficult for the patient to complete the study protocol;
• Refusal to sign the 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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 4, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-08