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Prognostic Value of Precision Medicine in Patients With MINOCA (PROMISE Trial). (PROMISE)

Primary Purpose

Myocardial Infarction With Non-Obstructive Coronary Arteries

Status

Recruiting

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Coronary angiography

OCT imaging

Percutaneous coronary intervention (PCI):

Acetylcholine provocative test

TT-Echocardiography

TE/contrast echocardiography

Cardiac magnetic resonance

Circulating biomarkers

Antiplatelet Drug

Statin

Beta blocker

ACEi/ARB

CCB

Nitrates

Anticoagulant

About this trial

This is an interventional treatment trial for Myocardial Infarction With Non-Obstructive Coronary Arteries focused on measuring MINOCA, coronary spasm, OCT

Eligibility Criteria

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

Inclusion Criteria:

Ability to give informed consent to the study
Age > 18y
MINOCA diagnosis, defined as:
- Acute myocardial infarction (based on Fourth Universal Definition of Myocardial Infarction Criteria):
- Evidence of non-obstructive coronary artery disease on angiography (i.e., no coronary artery stenosis >50%) in any major epicardial vessel.
- No specific alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, and myocarditis).

Exclusion Criteria:

Inability or limited capacity to give informed consent to the study
Age < 18 y
Pregnant and breast-feeding women or patients considering becoming pregnant during the study period will be excluded. For women of childbearing potential, the use of a highly effective contraceptive measure is required in order to be included in the study. "Highly effective contraceptive" is defined in accordance with the recommendations of the Clinical Trial Facilitation Group as a contraceptive measure with a failure rate of less than 1% per year (https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraception_guidance_Version_1.1_updated.pdf).
Alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, valve disease, hypertrophic cardiomyopathy and myocarditis). Also patients presenting with Takotsubo syndrome will be excluded.
Contraindication to contrast-enhanced CMR, eg, severe renal dysfunction (glomerular filtration rate <30 mL/min), non-CMR-compatible pacemaker or defibrillator.
Contraindication to drugs administrated: e.g a history of hypersensitivity to drugs administrated or its excipients, significant renal and/or hepatic disease.
Patients with comorbidities having an expected survival <1-year will be excluded.

Sites / Locations

Centro Cardiologico MonzinoRecruiting
Fondazione Policlinico Universitario A. Gemelli IRCCSRecruiting
IRCCS Policlinico San Donato

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

"Precision medicine approach"

"Standard approach"

Arm Description

Comprehensive diagnostic work-up with: Coronary angiography and ventriculography in all patients OCT at the time of coronary angiography in the cath-lab. Acetylcholine provocative test (to assess the presence of coronary vasospasm) at the time of coronary angiography in the cath-lab. TE-Echo and/or CE-Echo (if distal/microvascular embolization is suspected) Blood sampling for circulating biomarkers and miRNA expression profile Trans-thoracic echocardiography in all patients during the index hospitalization CMR in all cases during the index hospitalization. Targeted pharmacological treatment specific for the underlying cause: DAPT ± stent implantation (if required), statins, beta-blockers, ACEi/ARB (in case of evidence of plaque rupture/erosion) CCB and/or nitrates (in case of documentation of coronary vasospasm) Anticoagulation (in case of coronary embolism).

Routine diagnostic work-up with: Coronary angiography and ventriculography Transthoracic echocardiography in all patients during the index hospitalization CMR with contrast media only if clinically indicated (i.e. to exclude myocarditis or takotsubo syndrome) Standard medical treatment with: DAPT in all patients Beta-blockers (if indicated by the clinical context, i.e. documentation of left ventricular ejection fraction <50%, tachycardia). High intensity statins in all patients ACEi/ARB (if clinically indicated).

Outcomes

Primary Outcome Measures

Angina status

Angina status will be evaluated using the single-item "angina stability scale" and the two-item "angina frequence scale" of the Seattle Angina Questionnaire (SAQ). Scores are calculated by summing items within a dimension and transforming it to a 0-100 scale, where 0 is the worst and 100 the best possible level of health. * To reduce the risk of detection and performance bias, a team of 2 cardiologists blinded to group allocation and belonging to an external cardiology unit will submit and collate the questionnaires from study participants.

Quality of life

Quality of life will be evaluated using the nine-item scale of "physical limitations scale", the three-item "treatment satisfaction scale" and two-item "disease perception scale" of the Seattle Angina Questionnaire (SAQ). Scores are calculated by summing items within a dimension and transforming it to a 0-100 scale, where 0 is the worst and 100 the best possible level of health. * To reduce the risk of detection and performance bias, a team of 2 cardiologists blinded to group allocation and belonging to an external cardiology unit will submit and collate the questionnaires from study participants.

Secondary Outcome Measures

Rates of major adverse cardiovascular events

Rates of major adverse cardiovascular events (MACE; composite of all-cause mortality; re-hospitalization for myocardial infarction, stroke or heart failure; repeated coronary angiography) will be evaluated at 1-year follow-up in MINOCA patients.

Healthcare primary related-costs

Healthcare primary related costs will be evaluated as mean costs (including procedures, tests, medicines).

Healthcare secondary related-costs

Healthcare secondary related-costs will be evaluated as mean quality adjusted life year (QALY) gained.

Healthcare secondary related-costs

Healthcare secondary related-costs will be evaluated as the incremental cost-effectiveness ratio (ICER) expressed as the cost per QALY.

Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.

Measurement of cardiac circulating biomarkers: -miRNAs (miR-16, miR-26a, miR-145, miR-222, miR-155-5p, miR-483-5p, miR-45): to measure miRNA reverse transcriptase polymerase chain reaction (RT-PCR) will be employed and results will be expressed in relative expression (2-ΔΔCT Method).

Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.

Measurement of cardiac circulating biomarkers: -Endothelin 1: It will be assessed through ELISA immunoassay and results will be expressed in Picograms per millilitre (pg/mL).

Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.

Measurement of cardiac circulating biomarkers: -Neuropeptide Y: It will be assessed through ELISA immunoassay and results will be expressed in Picograms per millilitre (pg/mL).

Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.

Measurement of cardiac circulating biomarkers: -soluble CD40 ligand: It will be assessed through ELISA immunoassay and results will be expressed in Picograms per millilitre (pg/mL).

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Morphological cardiac characterization will be assessed by measurement of left and right ventricle volumes (in ml or ml/m2).

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Morphological cardiac characterization will be assessed by measurement of the presence of myocardial edema using T2-weighted sequences and a 17 segments assessment model of cardiac segmentation.

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Morphological cardiac characterization will be assessed by measurement of the presence of defect of perfusion using first pass perfusion sequences and a 17 segments assessment model of cardiac segmentation.

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Morphological cardiac characterization will be assessed by measurement of the presence of fibrosis using late gadolinium enhancement sequences and a 17 segments assessment model of cardiac segmentation (estimated as LGE % of the cardiac segment involved).

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Morphological cardiac characterization will be assessed by measurement of the presence of myocardial infarct size (estimated as grams or % of left ventricular myocardial mass).

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Functional cardiac characterization will be assessed by measurement of right and left ventricles eject fraction (estimated as %).

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Functional cardiac characterization will be assesaed by measurement of regional kinetic abnormalities using a 17 segments assessment model of cardiac segmentation.

Full Information

NCT ID

NCT05122780

First Posted

July 23, 2021

Last Updated

November 4, 2021

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Centro Cardiologico Monzino, IRCCS Policlinico S. Donato

1. Study Identification

Unique Protocol Identification Number

NCT05122780

Brief Title

Prognostic Value of Precision Medicine in Patients With MINOCA (PROMISE Trial).

Acronym

PROMISE

Official Title

PROgnostic Value of Precision Medicine in Patients With Myocardial Infarction and Non-obStructive Coronary artEries: the PROMISE Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Centro Cardiologico Monzino, IRCCS Policlinico S. Donato

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of our study is to evaluate if the use of a precision-medicine approach with a specific therapy tailored on the underlying pathogenic mechanism will improve the quality-of-life in MINOCA patients. The investigators further aim at investigating wherever a precision-medicine approach will improve the prognosis, healthcare related costs, and if that a different profile of plasma biomarkers and microRNAs may serve as diagnostic tools for detecting specific causes of MINOCA and to assess response to therapy. Finally, beyond its pivotal role in differential diagnosis, the investigators hypothesize that cardiac magnetic resonance (CMR) may provide a morphological and functional cardiac characterization as well as help in the prognostic stratification.

Detailed Description

PROMISE study is a randomized multicenter prospective superiority phase IV trial comparing "precision medicine approach" versus "standard of care" in improving the prognosis and/or the quality-of-life of patients presenting with MINOCA. Patients will be randomized 1:1 to "precision medicine approach" consisting of a comprehensive diagnostic work up aim at elucidating the pathophysiological mechanism of MINOCA and consequently a tailored pharmacological approach versus "standard of care" consisting of standard diagnostic algorithm and therapy for myocardial infarction. The aim of the study is to evaluate if the use of a precision-medicine approach with a specific therapy tailored on the underlying pathogenic mechanism will improve the quality-of-life in MINOCA patients (primary objective). The investigators further aim at investigating wherever a precision-medicine approach will improve the prognosis, healthcare related costs, and if that a different profile of plasma biomarkers and microRNAs may serve as diagnostic tools for detecting specific causes of MINOCA and to assess response to therapy (secondary objectives). Finally, beyond its pivotal role in differential diagnosis, the investigators hypothesize that cardiac magnetic resonance (CMR) may provide a morphological and functional cardiac characterization as well as help in the prognostic stratification (secondary objective). The study is a multicentre trial involving 3 centers: IRCCS Fondazione Policlinico Universitario A. Gemelli (Study Promoter), Centro Cardiologico Monzino IRCCS, IRCCS Policlinico San Donato. It will include 180 patients aged >18 years hospitalized for MINOCA randomized 1:1 to a "precision medicine approach" consisting of a comprehensive diagnostic work-up, analysis of circulating biomarkers and micro RNA expression profile and pharmacological treatment specific for the underlying cause versus a "standard approach" consisting of routine diagnostic work-up and standard medical treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction With Non-Obstructive Coronary Arteries

Keywords

MINOCA, coronary spasm, OCT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Patients will be randomized 1:1 (using an online software available 24h/24h) to "precision medicine approach" vs "standard approach".

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

"Precision medicine approach"

Arm Type

Active Comparator

Arm Description

Arm Title

"Standard approach"

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Coronary angiography

Intervention Description

coronary angiography will be performed via the transradial or transfemoral approach with the use of a 6F sheath. Coronary angiography will be performed within 90 minutes from hospital admission in patients presenting with persistent ST-segment elevation, and within 48 hours in patients presenting with non-ST-segment elevation. Unfractionated heparin (initial weight-adjusted intravenous bolus of 60 IU/Kg, with repeat boluses to achieve an activated clotting time of 250 to 300 seconds) was administered in all patients. If evidence of plaque rupture

Intervention Type

Diagnostic Test

Intervention Name(s)

OCT imaging

Intervention Description

OCT imaging will be performed in the culprit artery in all patients randomized to the "precision medicine approach". A 0.014-inch guidewire will be placed distally in the target vessel and an intracoronary injection of 200 µg of nitroglycerine will be performed. Frequency domain OCT (FD-OCT) images are acquired by a commercially available system (C7 System, LightLab Imaging Inc/ St Jude Medical, Westford, MA) connected to an OCT catheter (C7 Dragonfly; LightLab Imaging Inc/ St Jude Medical, Westford, MA), which was advanced to the culprit lesion. The FD-OCT run will be performed using the integrated automated pullback device at 20 mm/s. During image acquisition, coronary blood flow will be replaced by continuous flushing of contrast media directly from the guiding catheter at a rate of 4 ml/s with a power injector in order to create a virtually blood-free environment.

Intervention Type

Procedure

Intervention Name(s)

Percutaneous coronary intervention (PCI):

Intervention Description

PCI with stent implantation will be considered in selected cases with evidences of plaque rupture

Intervention Type

Diagnostic Test

Intervention Name(s)

Acetylcholine provocative test

Intervention Description

ACh will be administered in a stepwise manner into the left coronary artery (LCA) (20-200 μg) or into the right coronary artery (RCA) (20-50 μg) over a period of 3 min with a 2-3 min interval between injections. Coronary angiography will be performed 1 min after each injection of these agents and/or when chest pain and/or ischaemic ECG shifts were observed. The decision of testing with provocative test LCA or RCA as first will be left to the discretion of the physicians; both LCA and RCA will be tested if the first test was negative. Angiographic responses during the provocative test will be assessed in multiple orthogonal views in order to detect the most severe narrowing and/or analysed by using computerized quantitative coronary angiography (QCA-CMS, Version 6.0, Medis-Software, Leiden, The Netherlands).

Intervention Type

Diagnostic Test

Intervention Name(s)

TT-Echocardiography

Intervention Description

TT-Echo will be used to calculate left and right ventricular and atrial dimensions, left and right ventricular systolic function, transmitral flow Doppler spectra, mitral and tricuspidal valve annulus tissue Doppler spectra, ejection time and stroke volume, inferior vena cava, aorta and pulmonary artery diameters and Doppler spectra, according to the recommendations of the American Society of Echocardiography.

Intervention Type

Diagnostic Test

Intervention Name(s)

TE/contrast echocardiography

Intervention Description

In patients with angiographic evidence or suspicion of distal microembolization, TE-Echo consisting of an echocardiographic probe inserted in to the oesophagus will be used to detect a hidden cardioembolic source (i.e. left atrial thrombus); in patients with suspected left ventricular source of cardioembolism, contrast echocardiography consisting of a 0.3ml solution of SONOVUE will be used.

Intervention Type

Diagnostic Test

Intervention Name(s)

Cardiac magnetic resonance

Intervention Description

CMR will be performed during hospital stay on a 1.5-T system equipped with a 32-channel cardiac coil. Patients underwent conventional CMR including cine, T2-weighted, first pass perfusion, and conventional breath-held late gadolinium enhancement (LGE).

Intervention Type

Diagnostic Test

Intervention Name(s)

Circulating biomarkers

Intervention Description

Blood sampling for circulating biomarkers and miRNA expression profile at the time or within 12 hours of coronary angiography. Blood sampling will be processed and analysed in the research laboratory of the Department of Cardiovascular Science. Biological aliquots will be preserved at XBiogem Biobank at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome (see section 33).

Intervention Type

Drug

Intervention Name(s)

Antiplatelet Drug

Intervention Description

acetylsalicylic acid (loading dose 250mg intravenously followed by 75mg orally) + P2Y12 receptor inhibitor (i.e. Clopidogrel, 300 or 600mg loading dose orally, followed by 75 mg orally daily).

Intervention Type

Drug

Intervention Name(s)

Statin

Intervention Description

i.e. atorvastatin; dosages titrated on the patient's clinical characteristics

Intervention Type

Drug

Intervention Name(s)

Beta blocker

Intervention Description

i.e. bisoprolol; dosages titrated on blood pressure, ECG, heart rate

Intervention Type

Drug

Intervention Name(s)

ACEi/ARB

Intervention Description

i.e. ramipril; dosages titrated on blood pressure, ECG, heart rate

Intervention Type

Drug

Intervention Name(s)

CCB

Intervention Description

i.e. diltiazem; dosages titrated on blood pressure, ECG, heart rate

Intervention Type

Drug

Intervention Name(s)

Nitrates

Intervention Description

i.e. nitroglycerine; dosages titrated on blood pressure, ECG, heart rate

Intervention Type

Drug

Intervention Name(s)

Anticoagulant

Intervention Description

i.e. warfarin; the selection of the anticoagulant agent will be based on the clinical scenario, contraindications etc

Primary Outcome Measure Information:

Title

Angina status

Description

Time Frame

1-year follow-up

Title

Quality of life

Description

Time Frame

1-year follow-up

Secondary Outcome Measure Information:

Title

Rates of major adverse cardiovascular events

Description

Time Frame

1-year follow-up

Title

Healthcare primary related-costs

Description

Healthcare primary related costs will be evaluated as mean costs (including procedures, tests, medicines).

Time Frame

1-year follow-up

Title

Healthcare secondary related-costs

Description

Healthcare secondary related-costs will be evaluated as mean quality adjusted life year (QALY) gained.

Time Frame

1-year follow-up

Title

Healthcare secondary related-costs

Description

Healthcare secondary related-costs will be evaluated as the incremental cost-effectiveness ratio (ICER) expressed as the cost per QALY.

Time Frame

1-year follow-up

Title

Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.

Description

Time Frame

during index hospitalization (at the time or within 12 hours of coronary angiography)

Title

Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.

Description

Measurement of cardiac circulating biomarkers: -Endothelin 1: It will be assessed through ELISA immunoassay and results will be expressed in Picograms per millilitre (pg/mL).

Time Frame

during index hospitalization (at the time or within 12 hours of coronary angiography)

Title

Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.

Description

Measurement of cardiac circulating biomarkers: -Neuropeptide Y: It will be assessed through ELISA immunoassay and results will be expressed in Picograms per millilitre (pg/mL).

Time Frame

during index hospitalization (at the time or within 12 hours of coronary angiography)

Title

Ability of different circulating biomarkers as diagnostic biomarker and stratification tool for specific causes of MINOCA.

Description

Measurement of cardiac circulating biomarkers: -soluble CD40 ligand: It will be assessed through ELISA immunoassay and results will be expressed in Picograms per millilitre (pg/mL).

Time Frame

during index hospitalization (at the time or within 12 hours of coronary angiography)

Title

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Description

Morphological cardiac characterization will be assessed by measurement of left and right ventricle volumes (in ml or ml/m2).

Time Frame

from day 3 to day 7 from the acute coronary event

Title

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Description

Morphological cardiac characterization will be assessed by measurement of the presence of myocardial edema using T2-weighted sequences and a 17 segments assessment model of cardiac segmentation.

Time Frame

from day 3 to day 7 from the acute coronary event

Title

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Description

Time Frame

from day 3 to day 7 from the acute coronary event

Title

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Description

Time Frame

from day 3 to day 7 from the acute coronary event

Title

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Description

Morphological cardiac characterization will be assessed by measurement of the presence of myocardial infarct size (estimated as grams or % of left ventricular myocardial mass).

Time Frame

from day 3 to day 7 from the acute coronary event

Title

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Description

Functional cardiac characterization will be assessed by measurement of right and left ventricles eject fraction (estimated as %).

Time Frame

from day 3 to day 7 from the acute coronary event

Title

Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value through morphological and functional cardiac characterization.

Description

Functional cardiac characterization will be assesaed by measurement of regional kinetic abnormalities using a 17 segments assessment model of cardiac segmentation.

Time Frame

from day 3 to day 7 from the acute coronary event

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to give informed consent to the study Age > 18y MINOCA diagnosis, defined as: Acute myocardial infarction (based on Fourth Universal Definition of Myocardial Infarction Criteria): Evidence of non-obstructive coronary artery disease on angiography (i.e., no coronary artery stenosis >50%) in any major epicardial vessel. No specific alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, and myocarditis). Exclusion Criteria: Inability or limited capacity to give informed consent to the study Age < 18 y Pregnant and breast-feeding women or patients considering becoming pregnant during the study period will be excluded. For women of childbearing potential, the use of a highly effective contraceptive measure is required in order to be included in the study. "Highly effective contraceptive" is defined in accordance with the recommendations of the Clinical Trial Facilitation Group as a contraceptive measure with a failure rate of less than 1% per year (https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraception_guidance_Version_1.1_updated.pdf). Alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, valve disease, hypertrophic cardiomyopathy and myocarditis). Also patients presenting with Takotsubo syndrome will be excluded. Contraindication to contrast-enhanced CMR, eg, severe renal dysfunction (glomerular filtration rate <30 mL/min), non-CMR-compatible pacemaker or defibrillator. Contraindication to drugs administrated: e.g a history of hypersensitivity to drugs administrated or its excipients, significant renal and/or hepatic disease. Patients with comorbidities having an expected survival <1-year will be excluded.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rocco A. Montone, MD, PhD

Phone

+39-06-30154187

roccoantonio.montone@policlinicogemelli.it

First Name & Middle Initial & Last Name or Official Title & Degree

Alice Bonanni, BSc,PhD

Phone

+39-06-30154187

alice.bonanni@unicatt.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicola Cosentino, MD

Organizational Affiliation

Centro Cardiologico Monzino

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Riccardo Gorla, MD

Organizational Affiliation

IRCCS Policlinico S. Donato

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centro Cardiologico Monzino

City

Milan

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicola Cosentino, MD

Nicola.Cosentino@cardiologicomonzino.it

Facility Name

Fondazione Policlinico Universitario A. Gemelli IRCCS

City

Rome

ZIP/Postal Code

00168

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rocco Montone, MD, PhD

Phone

+39-0630154187

roccoantonio.montone@policlinicogemelli.it

Facility Name

IRCCS Policlinico San Donato

City

San Donato Milanese

ZIP/Postal Code

20097

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Riccardo Gorla

Phone

+39-02527741

R.gorla@hotmail.it

12. IPD Sharing Statement

Plan to Share IPD

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Prognostic Value of Precision Medicine in Patients With MINOCA (PROMISE Trial).

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