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

NCT ID: NCT05122780

Last Updated: 2024-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction With Non-Obstructive Coronary Arteries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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"Precision medicine approach"

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).

Group Type ACTIVE_COMPARATOR

Coronary angiography

Intervention Type PROCEDURE

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

OCT imaging

Intervention Type DIAGNOSTIC_TEST

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.

Percutaneous coronary intervention (PCI):

Intervention Type PROCEDURE

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

Acetylcholine provocative test

Intervention Type DIAGNOSTIC_TEST

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).

TT-Echocardiography

Intervention Type DIAGNOSTIC_TEST

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.

TE/contrast echocardiography

Intervention Type DIAGNOSTIC_TEST

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.

Cardiac magnetic resonance

Intervention Type DIAGNOSTIC_TEST

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).

Circulating biomarkers

Intervention Type DIAGNOSTIC_TEST

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).

Antiplatelet Drug

Intervention Type DRUG

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).

Statin

Intervention Type DRUG

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

Beta blocker

Intervention Type DRUG

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

ACEi/ARB

Intervention Type DRUG

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

CCB

Intervention Type DRUG

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

Nitrates

Intervention Type DRUG

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

Anticoagulant

Intervention Type DRUG

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

"Standard approach"

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).

Group Type OTHER

Coronary angiography

Intervention Type PROCEDURE

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

TT-Echocardiography

Intervention Type DIAGNOSTIC_TEST

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.

Cardiac magnetic resonance

Intervention Type DIAGNOSTIC_TEST

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).

Antiplatelet Drug

Intervention Type DRUG

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).

Statin

Intervention Type DRUG

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

Beta blocker

Intervention Type DRUG

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

ACEi/ARB

Intervention Type DRUG

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

Interventions

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Coronary angiography

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 PROCEDURE

OCT imaging

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 DIAGNOSTIC_TEST

Percutaneous coronary intervention (PCI):

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

Intervention Type PROCEDURE

Acetylcholine provocative test

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

TT-Echocardiography

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

TE/contrast echocardiography

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

Cardiac magnetic resonance

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

Circulating biomarkers

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 DIAGNOSTIC_TEST

Antiplatelet Drug

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

Statin

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

Intervention Type DRUG

Beta blocker

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

Intervention Type DRUG

ACEi/ARB

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

Intervention Type DRUG

CCB

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

Intervention Type DRUG

Nitrates

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

Intervention Type DRUG

Anticoagulant

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Cardiologico Monzino

OTHER

Sponsor Role collaborator

IRCCS Policlinico S. Donato

OTHER

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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MONTONE ROCCO ANTONIO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicola Cosentino, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Cardiologico Monzino

Riccardo Gorla, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico S. Donato

Locations

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Centro Cardiologico Monzino

Milan, , Italy

Site Status

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, , Italy

Site Status

IRCCS Policlinico San Donato

San Donato Milanese, , Italy

Site Status

Countries

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Italy

References

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Montone RA, Cosentino N, Graziani F, Gorla R, Del Buono MG, La Vecchia G, Rinaldi R, Marenzi G, Bartorelli AL, De Marco F, Testa L, Bedogni F, Trani C, Liuzzo G, Niccoli G, Crea F. Precision medicine versus standard of care for patients with myocardial infarction with non-obstructive coronary arteries (MINOCA): rationale and design of the multicentre, randomised PROMISE trial. EuroIntervention. 2022 Dec 2;18(11):e933-e939. doi: 10.4244/EIJ-D-22-00178.

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Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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GR-2019-12370197

Identifier Type: -

Identifier Source: org_study_id

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