Coronary Physiology Testing in Acute Coronary Syndromes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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ST Elevation Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

interventional, prospective, multicentre study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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STEMI acute myocardial infarction treated with effective primary PCI

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.

Group Type EXPERIMENTAL

PCI, invasive coronary physiology and CMR

Intervention Type 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

Interventions

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PCI, invasive coronary physiology and CMR

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No