NCT06588244Recruiting
INOCA-NA a Local Prospective Registry
Ischemia in Patients with Non- Obstructive Disease (INOCA) - a Local Prospective Registry (INOCA-Naples)
Source: ClinicalTrials.gov · Last updated 17 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 29 Aug 2024
- Start date
- 19 Sept 2024
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Federico II University
- Diseases
- Coronary artery disease
- NCT number
- NCT06588244
What you commit to
- Study type: Observational
- Planned participants: 250
- From 19 Sept 2024 to the primary completion date, 1 Sept 2026
- 1 site in 1 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 coronary artery bypass grafting (CABG);
Other illness
- Clinical presentation of acute coronary syndrome (ACS) or cardiogenic shock;
- Severe valvular heart disease;
- Known hypersensitivity or contraindication to any of the drugs used for coronary physiology testing (adenosine, nitrates, acetylcholine)
Lab values
- Left ventricular systolic dysfunction, defined as ejection fraction (EF) \<40%;
Other
- 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);
- Pregnant or breastfeeding women
- Inability or unwillingness to provide a valid in- formed consent to the study procedure at the time of baseline evaluation.
Who the study is looking for
- 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;
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| DPT of Advanced Biomedical Sciences Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.