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Coronary Physiology Testing in Acute Coronary Syndromes (CoPhyTea)

Primary Purpose

ST Elevation Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PCI, invasive coronary physiology and CMR
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ST Elevation Myocardial Infarction focused on measuring coronary microcirculation, coronary physiology, CMR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

  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.

Sites / Locations

  • IRCCS AOU San Martino
  • IRCCS Centro Cardiologico Monzino
  • IRCCS Ospedale San Raffaele
  • IRCCS Policlinico Gemelli
  • IRCCS Multimedica

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STEMI acute myocardial infarction treated with effective primary PCI

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 15, 2020
Last Updated
October 3, 2023
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT04677257
Brief Title
Coronary Physiology Testing in Acute Coronary Syndromes
Acronym
CoPhyTea
Official Title
Coronary Physiology Testing in Acute Coronary Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
coronary microcirculation, coronary physiology, CMR

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
interventional, prospective, multicentre study
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STEMI acute myocardial infarction treated with effective primary PCI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PCI, invasive coronary physiology and CMR
Intervention Description
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
Primary Outcome Measure Information:
Title
Defining the predictive value of the classification of patients based on coronary physiology
Description
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.
Time Frame
5 ± 2 days of the acute event.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo G Camici, MD, FACC
Organizational Affiliation
Ospedale San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS AOU San Martino
City
Genova
Country
Italy
Facility Name
IRCCS Centro Cardiologico Monzino
City
Milano
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
IRCCS Policlinico Gemelli
City
Roma
Country
Italy
Facility Name
IRCCS Multimedica
City
Sesto San Giovanni
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Coronary Physiology Testing in Acute Coronary Syndromes

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