Coronary Physiology Testing in Acute Coronary Syndromes (CoPhyTea)

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.

Study Overview

• Status: Completed
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Procedure: PCI, invasive coronary physiology and CMR

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo G Camici, MD, FACC; Phone Number: +39-022643-6202; Email: camici.paolo@hsr.it
• Study Contact Backup: Name: Virna Vittozzi; Phone Number: +39-022643-6206; Email: vittozzi.virna@hsr.it

Study Locations

• Italy
  • Genova, Italy
    • IRCCS AOU San Martino
  • Milan, Italy, 20132
    • IRCCS Ospedale San Raffaele
  • Milano, Italy
    • IRCCS Centro Cardiologico Monzino
  • Roma, Italy
    • IRCCS Policlinico Gemelli
  • Sesto San Giovanni, Italy
    • IRCCS Multimedica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Paolo G Camici, MD, FACC, Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: CMR; coronary microcirculation; coronary physiology
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Acute Coronary Syndrome
• Other Study ID Numbers: CoPhyTeA Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No