NCT05164640Completed
Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry"
Source: ClinicalTrials.gov · Last updated 9 Apr 2024
Brief summary (registry, in English)
Prospective, interventional, multicentre, non-randomized, single-arm open-label study that aims to enroll 200 consecutive patients with suspected chronic ischemic heart disease in the absence of obstructive coronary artery disease (INOCA) at clinically indicated coronary angiography in 3 Italian centers. During coronary angiography, these patients will be simultaneously subjected to a functional and coronary physiology study (according to the methods reported below): * Functional evaluation with fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), Resting Full-Cycle Ratio (RFR) of angiographic stenosis\> 50%; * In the presence of coronary angiographic stenosis \<50% or\> 50% but in the presence of a negative functional assessment (FFR\> 0.80 and iFR / RFR\> 0.90), coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be measured. IMR and CFR will be assessed using intra-coronary guidance; * In the presence of CFR\> 2.0 and IMR \<25, tests with acetylcholine will also be performed in order to evaluate the possible presence of epicardial (focal or diffuse) or microvascular spasm.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 8 Oct 2021
- Start date
- 1 Dec 2021
- Primary completion date
- 29 Feb 2024
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Coronary artery disease
- NCT number
- NCT05164640
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 1 Dec 2021 to the primary completion date, 29 Feb 2024
- 3 sites 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 diameter stenosis \>50% and FFR ≤0.80 (or iFR/RFR ≤0.89)
- Pregnant or breastfeeding women
- Inability or unwillingness to provide a valid informed consent to the study procedure at the time of baseline evaluation
Who the study is looking for
- Clinical presentation of chronic ischemic heart disease (IHD), requiring coronary angiography for the diagnosis
- Absence of obstructive CAD at coronary angiography
- Age \> 18 years
- Ability to provide a valid informed consent to the study procedure at the time of baseline evaluation
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Raffaele Hospital Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.