| NCT ID | NCT06588244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federico II University |
| Condition | Ischemia, Myocardial |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-09-19 |
| Primary Completion | 2026-09-01 |
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 250 participants in total. It began in 2024-09-19 with a primary completion date of 2026-09-01.
⚠ 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
The present study has the following objectives: 1. To investigate the prevalence of INOCA in patients referring for a clinically indicated coronary angiography (CA) c/o Division of Cardiology - Federico II University Hospital; 2. To stratify in INOCA endotypes patients according to the presence or absence of alternative (i.e. non obstructive CAD) causes of myocardial ischemia detected during CA clinically indicated through physiology tests; 3. to implement a stratified therapy in these patients considering the different INOCA endotypes and evaluate the impact on angina class and quality of life as well as cardiac hospitalization and coronary revascularization during 5 year follow up
Eligibility Criteria
Inclusion Criteria: * Clinical presentation of chronic ischemic heart dis- ease (IHD), requiring coronary angiography for the diagnosis; * Absence of obstructive coronary artery disease (CAD) at coronary angiography; * Age \> 18 years. * Ability to provide a valid informed consent to the study procedure at the time of baseline evaluation; Exclusion Criteria: Clinical presentation of acute coronary syndrome (ACS) or cardiogenic shock; * Presence of obstructive CAD with at least 1 significant coronary artery stenosis, defined as diameterstenosis \>50% and FFR ≤0.80 (or iFR/RFR ≤0.89); * Previous coronary artery bypass grafting (CABG); * Left ventricular systolic dysfunction, defined as ejection fraction (EF) \<40%; * Severe valvular heart disease; * Pregnant or breastfeeding women * Known hypersensitivity or contraindication to any of the drugs used for coronary physiology testing (adenosine, nitrates, acetylcholine) * Inability or unwillingness to provide a valid in- formed consent to the study procedure at the time of baseline evaluation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06588244 clinical trial?
This trial is open to participants of all sexes, studying Ischemia, Myocardial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06588244 currently recruiting?
Yes, NCT06588244 is actively recruiting participants. Contact the research team at luigi.diserafino@unina.it for enrollment information.
Where is the NCT06588244 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT06588244 clinical trial?
NCT06588244 is sponsored by Federico II University. The trial plans to enroll 250 participants.