NCT07805187Not yet recruiting
Non-Invasive Coronary Functional Evaluation of Patients With Single-vessel Coronary Artery Disease
Non-Invasive Coronary Functional Evaluation of Patients With Single-vessel Coronary Artery Disease Treated With Percutaneous Coronary Intervention
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 27 Aug 2026
- Start date
- Oct 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Coronary artery disease
- NCT number
- NCT07805187
What you commit to
- Study type: Interventional
- Planned participants: 32
- From Oct 2026 to the primary completion date, Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of specific heart disease, e.g., ischemic (previous percutaneous or surgical myocardial revascularization, myocardial infarction), valvular, congenital heart disease or cardiomyopathy;
Other illness
- 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);
- Multivessel coronary artery disease;
- 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;
Lab values
- Serious medical conditions, including renal failure (eGFR \<30 mL/min), liver diseases, malignancies, and acute or chronic inflammatory diseases;
Other
- Contraindication to dipyridamole;
- Pregnancy;
- Refusal to sign the informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.