Coronary Physiology Testing in Acute Coronary Syndromes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ST Elevation Myocardial Infarction
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 130
- Locations
- 5
- Primary Endpoint
- Defining the predictive value of the classification of patients based on coronary physiology
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 ability of coronary physiology parameters measured soon after recanalization to predict myocardial tissue characterization assessed with cardiac magnetic resonance (CMR) within a week of the acute event. Furthermore, patients will be followed up for a period of 12 months to assess the incidence of major adverse cardiovascular events (death, death from cardiovascular causes, re-infarction, new coronary revascularization interventions, development of heart failure) based on their stratification according to coronary physiology parameters.
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 parameters, i.e. coronary flow reserve (CFR) and index of microvascular resistance (IMR) measured after recanalization to predict myocardial tissue characterization (MVO, MSI, IS, T2-rt, T1-rt and ECV) assessed with contrast CMR within a week of the acute event. Furthermore, the relationship between left ventricular end-diastolic pressure and of coronary physiology parameters will be evaluated.
Investigators
Prof. Paolo G Camici MD FACC
Prof Paolo G. Camici MD, FACC
IRCCS San Raffaele
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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;
Outcomes
Primary Outcomes
Defining the predictive value of the classification of patients based on coronary physiology
Time Frame: 5 ± 2 days of the acute event.
Establish the predictive value of the classification of patients based on coronary physiology measured in acute after primary PCI in patients with STEMI, on the incidence of microvascular obstruction (MVO) measured with CMR with contrast medium within 5 ± 2 days of the acute event.