PCI PatientsNICE-CAD-PCINCT07805187
Non-Invasive Coronary Functional Evaluation of Patients With Single-vessel Coronary Artery Disease
A study testing Coronary flow reserve assessed by Echocardiography in people with PCI Patients and Single Coronary Vessel Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PCI Patients, Single Coronary Vessel Disease
- What is being tested?
- Coronary flow reserve assessed by Echocardiography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: Non-Invasive Coronary Functional Evaluation of Patients With Single-vessel Coronary Artery Disease Treated With Percutaneous Coronary Intervention
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.
Read more
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.
Read the detailed description
Within four weeks after PCI, all enrolled patients will undergo a comprehensive non-invasive coronary functional evaluation using transthoracic Doppler echocardiography (TTDE). After a 10-minute resting period, a complete baseline echocardiographic examination will be performed, including assessment of global and regional left ventricular wall motion. The mid-distal left anterior descending coronary artery (LAD) will then be identified by color Doppler imaging, and peak diastolic coronary blood flow velocity (CBFV) will be measured using pulsed-wave Doppler.
Coronary vascular function will subsequently be assessed using three sequential coronary functional tests performed under continuous 12-lead electrocardiographic monitoring, intermittent blood pressure measurements, and peripheral oxygen saturation monitoring, with a 15-minute recovery interval between tests.
The hyperventilation test will be performed by asking participants to breathe deeply and rapidly at a rate of approximately 30 breaths per minute for 5 minutes. The cold pressor test will consist of immersion of the participant's right hand in ice water for 2 minutes. Finally, dipyridamole will be administered intravenously at a dose of 0.84 mg/kg over 6 minutes to assess endothelium-independent coronary vasodilator capacity.
Coronary blood flow velocity will be measured at baseline and at the peak of each functional test. The ratio between peak and baseline CBFV will be calculated for each stimulus as an index of coronary vascular function. Symptoms, electrocardiographic changes, and inducible regional wall motion abnormalities will also be recorded throughout the examination. Patients receiving beta-blockers or calcium channel blockers will be asked to temporarily discontinue these medications for 48 hours before the study examination.
The primary endpoint is the comparison of coronary flow reserve measured during dipyridamole stress between the LAD and non-LAD groups.
Secondary analyses will evaluate the association between abnormal coronary functional responses and adverse clinical outcomes. Participants will undergo structured clinical follow-up six months after PCI through telephone contact. Information regarding recurrent angina, repeat coronary angiography, target lesion revascularization, myocardial infarction, cardiovascular death, or other cardiovascular events will be collected. Reported events will be verified through review of electronic medical records or hospital documentation whenever available.
The study is powered to detect clinically meaningful differences in coronary flow reserve between the two study groups. Statistical analyses will compare coronary functional parameters between groups using appropriate parametric or non-parametric methods according to data distribution. Multivariable generalized linear models will be used to account for potential confounding variables, while Cox proportional hazards regression analyses will evaluate the relationship between coronary functional abnormalities and six-month clinical outcomes after adjustment for relevant clinical characteristics.
- Conditions
- PCI Patients, Single Coronary Vessel Disease
- Being tested
- Coronary flow reserve assessed by Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary flow reserve assessed by EchocardiographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Coronary flow reserve assessed by Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of the procedure
Secondary outcomes (1)
Incidence of major adverse cardiovascular events (MACE) according to the presence of functional coronary abnormalities
The incidence of major adverse cardiovascular events (MACE) at 6-month follow-up will be assessed according to the presence or absence of functional coronary abnormalities detected by transthoracic Doppler echocardiography (TTDE) during coronary functional testing. MACE will be defined as a composite of cardiovascular death, myocardial infarction, and target vessel revascularization (percutaneous or surgical). The outcome will be reported as the number and percentage of patients experiencing at least one MACE during follow-up.
Measured: 6-months after the enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCI PatientsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805187
- Sponsor's protocol ID
- 26956
- Acronym
- NICE-CAD-PCI
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Coronary Functional Evaluation of Patients With Single-vessel Coronary Artery Disease Treated With Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07805187
- Acronym / sponsor ID
- NICE-CAD-PCI / 26956
- Conditions
- PCI Patients, Single Coronary Vessel Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Within four weeks after PCI, all enrolled patients will undergo a comprehensive non-invasive coronary functional evaluation using transthoracic Doppler echocardiography (TTDE). After a 10-minute resting period, a complete baseline echocardiographic examination will be performed, including assessment of global and regional left ventricular wall motion. The mid-distal left anterior descending coronary artery (LAD) will then be identified by color Doppler imaging, and peak diastolic coronary blood flow velocity (CBFV) will be measured using pulsed-wave Doppler.
Coronary vascular function will subsequently be assessed using three sequential coronary functional tests performed under continuous 12-lead electrocardiographic monitoring, intermittent blood pressure measurements, and peripheral oxygen saturation monitoring, with a 15-minute recovery interval between tests.
The hyperventilation test will be performed by asking participants to breathe deeply and rapidly at a rate of approximately 30 breaths per minute for 5 minutes. The cold pressor test will consist of immersion of the participant's right hand in ice water for 2 minutes. Finally, dipyridamole will be administered intravenously at a dose of 0.84 mg/kg over 6 minutes to assess endothelium-independent coronary vasodilator capacity.
Coronary blood flow velocity will be measured at baseline and at the peak of each functional test. The ratio between peak and baseline CBFV will be calculated for each stimulus as an index of coronary vascular function. Symptoms, electrocardiographic changes, and inducible regional wall motion abnormalities will also be recorded throughout the examination. Patients receiving beta-blockers or calcium channel blockers will be asked to temporarily discontinue these medications for 48 hours before the study examination.
The primary endpoint is the comparison of coronary flow reserve measured during dipyridamole stress between the LAD and non-LAD groups.
Secondary analyses will evaluate the association between abnormal coronary functional responses and adverse clinical outcomes. Participants will undergo structured clinical follow-up six months after PCI through telephone contact. Information regarding recurrent angina, repeat coronary angiography, target lesion revascularization, myocardial infarction, cardiovascular death, or other cardiovascular events will be collected. Reported events will be verified through review of electronic medical records or hospital documentation whenever available.
The study is powered to detect clinically meaningful differences in coronary flow reserve between the two study groups. Statistical analyses will compare coronary functional parameters between groups using appropriate parametric or non-parametric methods according to data distribution. Multivariable generalized linear models will be used to account for potential confounding variables, while Cox proportional hazards regression analyses will evaluate the relationship between coronary functional abnormalities and six-month clinical outcomes after adjustment for relevant clinical characteristics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAD group | Other | Diagnostic Test: Coronary flow reserve assessed by EchocardiographyPatients 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. |
| Non-LAD group | Other | Diagnostic Test: Coronary flow reserve assessed by EchocardiographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary flow reserve assessed by EchocardiographyAll 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. | Diagnostic test | LAD group, Non-LAD group |
Primary outcome
Difference in coronary flow reserve (CFR) between the LAD and non-LAD groups
Time frame: Duration of the procedure
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.
1 secondary outcome
Incidence of major adverse cardiovascular events (MACE) according to the presence of functional coronary abnormalities
Time frame: 6-months after the enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary flow reserve assessed by Echocardiography in people with PCI Patients and Single Coronary Vessel Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in coronary flow reserve (CFR) between the LAD and non-LAD groups (time frame: Duration of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.