Coronary Physiology Testing in Acute Coronary Syndromes

NCT04677257 | Completed DMC

• 1 other identifier: CoPhyTeA Trial
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 5

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.

Conditions

ST Elevation Myocardial Infarction

Keywords

coronary microcirculation; coronary physiology; CMR

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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.

Procedure: PCI, invasive coronary physiology and CMR

Interventions

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

STEMI acute myocardial infarction treated with effective primary PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (5)

IRCCS AOU San Martino

Genova, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

IRCCS Centro Cardiologico Monzino

Milan, Italy

Location

IRCCS Policlinico Gemelli

Roma, Italy

Location

IRCCS Multimedica

Sesto San Giovanni, Italy

Location

Related Publications (1)

• 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.

  PMID: 37879880 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Paolo G Camici, MD, FACC

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Paolo G. Camici MD, FACC

Model Details: interventional, prospective, multicentre study

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: November 2, 2020
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2022
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)