Status:
COMPLETED
Coronary Physiology Testing in Acute Coronary Syndromes
Lead Sponsor:
IRCCS San Raffaele
Conditions:
ST Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an interventional, prospective, multicenter study (5 IRCCS hospitals belonging to the Italian Cardiology Network) in patients with STEMI treated with successful primary PCI to assess the abili...
Detailed Description
In the present study the investigators will enroll consecutive patients with STEMI acute myocardial infarction treated with successful primary PCI, to assess the ability of coronary physiology paramet...
Eligibility Criteria
Inclusion
- Patients with STEMI (defined according to ESC Guidelines 2017), with symptom onset within 12 hours (Class I), or between 12 and 48 hours (Class IIa), (1) successfully treated with primary PCI. (1)
Exclusion
- Patients with previous myocardial infarction in the territory of the infarct-related artery;
- Patients with previous coronary artery bypass grafting;
- Patients with cardiogenic shock at presentation;
- Patients with need for mechanical support of the circulation;
- Patients with known severe aortic stenosis / insufficiency;
- Patients with known cardiomyopathy;
- Patients with malignant neoplasm or systemic pathology with a "quoad vitam" prognosis of less than 1 year;
- Patients affected by known active infectious diseases;
- Women who are pregnant or breastfeeding;
- Patients who are unable to express valid informed consent upon enrollment;
- Patients with hypersensitivity to the active ingredients used for the study of coronary physiology (nitrates and adenosine);
- Patients with specific contraindications to cardiac magnetic resonance imaging, including:
- Patients with allergies and / or with other specific contraindications to the use of paramagnetic contrast media (gadolinium), including chronic renal failure with glomerular filtrate (eGFR) \<30 mL / min;
- Patients with non-resonance-compatible devices or who have undergone previous surgical interventions with placement of non-resonance-compatible vascular clips;
- Claustrophobic patients.
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04677257
Start Date
November 2 2020
End Date
December 31 2022
Last Update
October 4 2023
Active Locations (5)
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1
IRCCS AOU San Martino
Genova, Italy
2
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
3
IRCCS Centro Cardiologico Monzino
Milan, Italy
4
IRCCS Policlinico Gemelli
Roma, Italy