Registry for patients with non-obstructive coronary artery disease
INOCA Spanish National Registry: ESP-INOCA
This study is collecting information from patients with non-obstructive coronary artery disease to see how their heart function affects their symptoms and overall health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital General Universitario de Valencia Academic / other |
| Locations | 3 sites (Madrid and 2 other locations) |
| Trial ID | NCT06327672 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on patients diagnosed with Ischemic Non-Obstructive Coronary Artery Disease (INOCA) who are undergoing invasive coronary function testing. It focuses on understanding the prevalence of microvascular dysfunction and its implications for patient outcomes. The study will assess symptoms, diagnostic criteria, and the occurrence of major adverse cardiac events in this population over time. By analyzing these factors, the study seeks to improve the management and treatment of patients with INOCA.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with anginal symptoms and positive tests for myocardial ischemia but without obstructive coronary artery disease.
Not a fit: Patients with moderate to severe valvular heart disease or structural heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic and treatment strategies for patients suffering from non-obstructive coronary artery disease.
How similar studies have performed: Other studies have shown success in understanding microvascular dysfunction in similar patient populations, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \> 18 years. * Anginal symptoms. * Anginal equivalent with positive myocardial ischaemia test. * Absence of obstructive coronary artery disease (diameter stenosis \<50% or \>50% with a FFR\>0.80). * Patients undergoing invasive coronary function test. * Signed informed consent. Exclusion Criteria: * Failure to meet inclusion criteria. * Patients with moderate-severe valvular heart disease. * Patients with structural heart disease. * Elevation of markers of myocardial necrosis.
Where this trial is running
Madrid and 2 other locations
- Hospital Universitario de la Princesa — Madrid, Spain (Recruiting)
- Hospital Universitario Virgen de Arrixaca — Murcia, Spain (Recruiting)
- Hospital General Universitario de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Eva Rumiz, MD, PhD
- Email: evarumizgonzalez@gmail.com
- Phone: +34 963131800
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.