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 type | Observational |
|---|---|
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples, Italy) |
| Status | Recruiting |
| Started | September 19, 2024 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2027 |
| Registry record updated | March 17, 2025 |
| Trial ID | NCT06588244 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
- Study coordinator: Luigi Di Serafino, MD, PhD
- Email: luigi.diserafino@unina.it
- Phone: 0039 347917374
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Stratified medicine approach for managing angina without obstructive coronary artery disease
This study is testing if a personalized treatment plan based on a special heart test can help people with angina who don’t have blocked arteries feel better and improve their health.
-
Women with chest pain and non-obstructive arteries: personalized diagnostic and treatment approach
This study tests a personalized diagnostic-and-treatment pathway for women with angina but non-obstructive coronary arteries to see if targeted therapy improves symptoms and quality of life.
-
COMA.NET: Targeted treatment for coronary microcirculation problems
This trial will test whether tailoring medicines based on intracoronary microvascular testing improves quality of life for people with ischemia but no large artery blockages.
-
Multi-sensor wireless pressure catheter to test microvascular function in people with angina and non-obstructive arteries
Doctors are testing a new wireless pressure catheter to see if it can accurately diagnose coronary microvascular dysfunction in people with angina but non-obstructive arteries, using MRI perfusion as the reference test.
-
How kidney transplant affects blood flow in the heart's tiny vessels in people with advanced CKD
This study will try to see if getting a kidney transplant improves blood flow in the small vessels of the heart for people with advanced chronic kidney disease who are on the transplant waitlist.
-
Nitrate Beetroot Juice to Help Blood Flow in Women with ANOCA and CMD
We’re testing whether nitrate-rich beetroot juice for 14 days can improve heart blood flow and quality of life for women with ANOCA and CMD compared with a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.