ST Elevation Myocardial InfarctionCoPhyTeaNCT04677257
Coronary Physiology Testing in Acute Coronary Syndromes
A study testing PCI, invasive coronary physiology and CMR in people with ST Elevation Myocardial Infarction, run by IRCCS San Raffaele at 5 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- PCI, invasive coronary physiology and CMR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 5 sitesItaly
- Study dates
- 2 Nov 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
IRCCS AOU San Martino
Genova
IRCCS Ospedale San Raffaele
Milan, 20132
IRCCS Centro Cardiologico Monzino
Milan
IRCCS Policlinico Gemelli
Roma
IRCCS Multimedica
Sesto San Giovanni
About this study
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.
Read the 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.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- PCI, invasive coronary physiology and CMR
- Keywords
- coronary microcirculation, coronary physiology, CMR
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI, invasive coronary physiology and CMRProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: PCI, invasive coronary physiology and CMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 ± 2 days of the acute event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start2 Nov 2020
- Primary completion30 Nov 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- interventional, prospective, multicentre study
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Paolo G Camici MD FACC, IRCCS San Raffaele
- Investigators
- Paolo G Camici, MD, FACC, Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677257
- Sponsor's protocol ID
- CoPhyTeA Trial
- Acronym
- CoPhyTea
- Status last verified
- Oct 2023
- First submitted
- 15 Dec 2020
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37879880
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Physiology Testing in Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT04677257
- Acronym / sponsor ID
- CoPhyTea / CoPhyTeA Trial
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- coronary microcirculation, coronary physiology, CMR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- interventional, prospective, multicentre study
| Arm | Type | Receives |
|---|---|---|
| STEMI acute myocardial infarction treated with effective primary PCI | Experimental | Procedure: PCI, invasive coronary physiology and CMRSTEMI 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI, invasive coronary physiology and CMRPatients 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 | Procedure or surgery | STEMI acute myocardial infarction treated with effective primary PCI |
Primary outcome
Defining the predictive value of the classification of patients based on coronary physiology
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Derived from this study: PubMed 37879880Benenati 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo G Camici, MD, FACC principal investigator
Ospedale San Raffaele
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI, invasive coronary physiology and CMR in people with ST Elevation Myocardial Infarction, run by IRCCS San Raffaele at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defining the predictive value of the classification of patients based on coronary physiology (time frame: 5 ± 2 days of the acute event.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04677257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.