Coronary Physiology Testing in Acute Coronary Syndromes

ST Elevation Myocardial Infarction Clinical Trial

— CoPhyTea  

Official title:

Coronary Physiology Testing in Acute Coronary Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04677257
• Other study ID #: CoPhyTeA Trial
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS AOU San Martino	Genova
Italy	IRCCS Ospedale San Raffaele	Milan
Italy	IRCCS Centro Cardiologico Monzino	Milano
Italy	IRCCS Policlinico Gemelli	Roma
Italy	IRCCS Multimedica	Sesto San Giovanni

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.