NCT07638137 Advanced Invasive Diagnosis Strategy for Post-PCI Patients With Stable Coronary Syndromes Undergoing Coronary Angiography
| NCT ID | NCT07638137 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion Investigacion Interhospitalaria Cardiovascular |
| Condition | Angina (Stable) |
| Study Type | OBSERVATIONAL |
| Enrollment | 246 participants |
| Start Date | 2025-03-12 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 246 participants in total. It began in 2025-03-12 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
AID Post-PCI Angina is as an observational, prospective, single-cohort, multicenter study designed to investigate the causes and origins of post-PCI angina by using the advance invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP) in an all-comers population of patients with post-PCI angina referred for invasive coronary angiography. An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI), who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography (ICA) will be enrolled. ICA will be performed with the application of the structure AID strategy to evaluate both obstructive and non-obstructive cause of myocardial ischemia. Then, angiography derived physiological assessment of epicardial coronary artery using functional coronary angiography in each vessel will be performed in both index procedure and the previous procedure in all patients. By combining information obtained from both procedures, the causes and origins of post-PCI angina will be made. Treatment will be decided by the operators according to the result. Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline and at 1, 6, and 12 months after the procedure. The main hypothesis of this study states that, in patients with post-PCI angina referred to ICA, the application of the structured AID strategy combining with angiography derived physiology (ADP) will lead to a high diagnostic yield in identifying the origins of obstructive disease and causes of post-PCI angina.
Eligibility Criteria
Inclusion Criteria: * Patients with a history of previous percutaneous coronary intervention (PCI) with drug eluting stent (DES), bare metallic stent (BMS), or drug coated balloon (DCB) due to acute coronary syndrome or chronic coronary syndrome, who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography. Exclusion Criteria: * Acute myocardial infarction (ST-segment elevation myocardial infarction \[STEMI\] and non-ST-segment elevation myocardial infarction \[NSTEMI\]). * Age \< 18 years old. * Pregnancy. * Severe left ventricle systolic dysfunction (left ventricular ejection fraction ≤30 %). * Congestive heart failure with reduced ejection fraction. * Concomitant severe valvular heart disease. * Severely decreased renal function (glomerular filtration rate \< 30 mL/min/1.73 m2). * Significant epicardial coronary artery disease unable to be treated by PCI. * Previous coronary artery bypass grafting (CABG). * Presence of any anatomic features precluding intracoronary instrumentation with pressure guidewires. * Contraindications to the administration of adenosine or acetylcholine.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07638137 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Angina (Stable). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07638137 currently recruiting?
Yes, NCT07638137 is actively recruiting participants. Contact the research team at escaned@secadiologia.es for enrollment information.
Where is the NCT07638137 trial being conducted?
This trial is being conducted at Leganés, Spain, Madrid, Spain, Madrid, Spain, Madrid, Spain and 1 additional location.
Who is sponsoring the NCT07638137 clinical trial?
NCT07638137 is sponsored by Fundacion Investigacion Interhospitalaria Cardiovascular. The trial plans to enroll 246 participants.