Registry for patients with non-obstructive coronary artery disease
Ischemia in Patients with Non- Obstructive Disease (INOCA) - a Local Prospective Registry (INOCA-Naples)
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 |
|---|---|
| Enrollment | 250 (estimated) |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples, Italy) |
| Trial ID | NCT06588244 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with chronic ischemic heart disease requiring coronary angiography and without obstructive coronary artery disease.
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.
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 performed: While similar studies have explored coronary microvascular dysfunction, this specific registry approach focusing on INOCA is relatively novel.
Eligibility criteria
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 this trial is running
Naples, Italy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.