CoPhyTea: Coronary Physiology Testing in Acute Coronary Syndromes

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Recruiting

CT.gov ID

NCT04677257

Collaborator

(none)

120

Enrollment

Locations

Arm

24.9

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ST Elevation Myocardial Infarction	Procedure: PCI, invasive coronary physiology and CMR	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

interventional, prospective, multicentre studyinterventional, prospective, multicentre study

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Coronary Physiology Testing in Acute Coronary Syndromes

Actual Study Start Date :

Nov 2, 2020

Actual Primary Completion Date :

Nov 30, 2021

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	IRCCS AOU San Martino	Genova	Italy
2	IRCCS Centro Cardiologico Monzino	Milano	Italy
3	IRCCS Ospedale San Raffaele	Milan	Italy	20132
4	IRCCS Policlinico Gemelli	Roma	Italy
5	IRCCS Multimedica	Sesto San Giovanni	Italy