Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEMI acute myocardial infarction treated with effective primary PCI | Experimental | STEMI patients treated with effective primary PCI to assess the ability of coronary physiology parameters (CFR and IMR) measured soon after recanalization to predict myocardial tissue characterization assessed with cardiac magnetic resonance (CMR) within a week of the acute event. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI, invasive coronary physiology and CMR | Procedure | Patients with acute STEMI will undergo invasive assessment of coronary physiology (IMR and CFR) following successful primary PCI and CMR within a week of the acute event |
| Measure | Description | Time Frame |
|---|---|---|
| Defining the predictive value of the classification of patients based on coronary physiology | 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. | 5 ± 2 days of the acute event. |
Not provided
Not provided
Inclusion Criteria:
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;
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paolo G Camici, MD, FACC | Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS AOU San Martino | Genova | Italy | ||||
| IRCCS Ospedale San Raffaele |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37879880 | Derived | Benenati S, Montorfano M, Pica S, Crimi G, Ancona M, Montone RA, Rinaldi R, Gramegna M, Esposito A, Palmisano A, Tavano D, Monizzi G, Bartorelli A, Porto I, Ambrosio G, Camici PG. Coronary physiology thresholds associated with microvascular obstruction in myocardial infarction. Heart. 2024 Jan 29;110(4):271-280. doi: 10.1136/heartjnl-2023-323169. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 29, 2025 | |
| Reset | May 15, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 29, 2025 | May 15, 2025 |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
interventional, prospective, multicentre study
Not provided
Not provided
Not provided
Not provided
| Milan |
| 20132 |
| Italy |
| IRCCS Centro Cardiologico Monzino | Milan | Italy |
| IRCCS Policlinico Gemelli | Roma | Italy |
| IRCCS Multimedica | Sesto San Giovanni | Italy |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |