Advanced invasive diagnosis for post-PCI angina in patients referred for coronary angiography

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, single-cohort observational study enrolling patients with a history of PCI who present with angina or ischemia and are referred for invasive coronary angiography. The study uses an advanced invasive diagnosis (AID) strategy combined with angiography-derived physiology (ADP) to evaluate both obstructive and non-obstructive causes of ischemia at index and prior procedures. The primary goal is to understand the origins of post-PCI angina, while a secondary objective assesses whether applying AID improves angina symptoms at 6 months, as measured by the Seattle Angina Questionnaire. The study is conducted across five hospitals in Spain and includes patients with DES, BMS, or DCB history due to ACS or CCS. Outcomes will include diagnostic findings and symptom changes to inform future patient care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario Severo Ochoa
  Leganés, Madrid, Spain Recruiting
• Hospital Clinico San Carlos
  Madrid, Madrid, Spain Recruiting
• Hospital General Universitario Gregorio Marañón
  Madrid, Madrid, Spain Recruiting
• Acalá de Henares
  Madrid, Madrid, Spain Recruiting
• Hospital Quirónsalud Valencia
  Valencia, Valencia, Spain Recruiting

Study contacts

• Study coordinator: Javier Escaned, MD, PhD
• Email: escaned@secadiologia.es
• Phone: (0034)913303000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.