Coronary Physiology Testing in Acute Coronary Syndromes

Not Applicable

Completed

• Conditions: ST Elevation Myocardial Infarction
• Interventions: Procedure: PCI, invasive coronary physiology and CMR

• Registration Number: NCT04677257
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study Start: 2020-11-02
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-21
• Primary Completion: 2021-11-30
• Study Completion: 2022-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STEMI acute myocardial infarction treated with effective primary PCI	PCI, invasive coronary physiology and CMR	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.

Primary Outcome Measures

Name	Time	Method
Defining the predictive value of the classification of patients based on coronary physiology	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.

Trial Locations

Locations (5)

IRCCS Centro Cardiologico Monzino; 🇮🇹 Milano, Italy

IRCCS Multimedica; 🇮🇹 Sesto San Giovanni, Italy

IRCCS AOU San Martino; 🇮🇹 Genova, Italy

IRCCS Policlinico Gemelli; 🇮🇹 Roma, Italy

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy