Coronary Physiology Testing in Acute Coronary Syndromes (CoPhyTea)

San Donato Group (GSD)

Status: Completed

Conditions: ST Elevation Myocardial Infarction

Treatments: Procedure: PCI, invasive coronary physiology and CMR

Study type: Interventional

Funder types: Other

Identifiers

NCT04677257

CoPhyTeA Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

1. Patients with previous myocardial infarction in the territory of the infarct-related artery;

2. Patients with previous coronary artery bypass grafting;

3. Patients with cardiogenic shock at presentation;

4. Patients with need for mechanical support of the circulation;

5. Patients with known severe aortic stenosis / insufficiency;

6. Patients with known cardiomyopathy;

7. Patients with malignant neoplasm or systemic pathology with a "quoad vitam" prognosis of less than 1 year;

8. Patients affected by known active infectious diseases;

9. Women who are pregnant or breastfeeding;

10. Patients who are unable to express valid informed consent upon enrollment;

11. Patients with hypersensitivity to the active ingredients used for the study of coronary physiology (nitrates and adenosine);

12. 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

STEMI acute myocardial infarction treated with effective primary PCI

Experimental group

Description:

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.

Treatment:

Procedure: PCI, invasive coronary physiology and CMR