Clinical trial Recruiting at 1 site Observational

Registry for patients with non-obstructive coronary artery disease

Official title: Ischemia in Patients with Non- Obstructive Disease (INOCA) - a Local Prospective Registry (INOCA-Naples)

Run by Federico II University · NCT06588244 · Data updated 2026-11-12

This study looks at people with non-obstructive coronary artery disease to see how common chest pain is and if personalized treatments can improve their symptoms and overall health over five years.

Quick facts

Study typeObservational
SexAll
Enrollment250 (estimated)
SponsorFederico II University
Academic / other
Locations1 site (Naples, Italy)
StatusRecruiting
StartedSeptember 19, 2024
Main results expectedSeptember 1, 2026
Study endsSeptember 1, 2027
Registry record updatedMarch 17, 2025
Trial IDNCT06588244 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years with chronic ischemic heart disease requiring coronary angiography and without obstructive coronary artery disease.

Probably not a fit

Patients with acute coronary syndrome, significant obstructive coronary artery disease, or severe valvular heart disease are unlikely to benefit from this study.

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

What this trial studies

This observational study aims to investigate the prevalence of ischemia in patients with non-obstructive coronary artery disease who are undergoing coronary angiography. It will stratify patients into different endotypes based on the presence of alternative causes of myocardial ischemia and implement tailored therapies. The study will evaluate the impact of these therapies on angina class, quality of life, and rates of cardiac hospitalization and coronary revascularization over a five-year follow-up period.

Why it matters

Potential benefit: If successful, this study could lead to improved management and treatment strategies for patients suffering from non-obstructive coronary artery disease.

How similar studies have gone: While similar studies have explored coronary microvascular dysfunction, this specific registry approach focusing on INOCA is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • DPT of Advanced Biomedical Sciences
    Naples, Italy, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.