Prognostic Value of Precision Medicine in Patients With MINOCA (PROMISE Trial).
NCT ID: NCT05122780
Last Updated: 2024-07-26
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2021-07-01
2025-07-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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).
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
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.
Percutaneous coronary intervention (PCI):
PCI with stent implantation will be considered in selected cases with evidences of plaque rupture
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).
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.
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.
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).
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).
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).
Statin
i.e. atorvastatin; dosages titrated on the patient's clinical characteristics
Beta blocker
i.e. bisoprolol; dosages titrated on blood pressure, ECG, heart rate
ACEi/ARB
i.e. ramipril; dosages titrated on blood pressure, ECG, heart rate
CCB
i.e. diltiazem; dosages titrated on blood pressure, ECG, heart rate
Nitrates
i.e. nitroglycerine; dosages titrated on blood pressure, ECG, heart rate
Anticoagulant
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).
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
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.
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).
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).
Statin
i.e. atorvastatin; dosages titrated on the patient's clinical characteristics
Beta blocker
i.e. bisoprolol; dosages titrated on blood pressure, ECG, heart rate
ACEi/ARB
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
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.
Percutaneous coronary intervention (PCI):
PCI with stent implantation will be considered in selected cases with evidences of plaque rupture
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).
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.
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.
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).
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).
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).
Statin
i.e. atorvastatin; dosages titrated on the patient's clinical characteristics
Beta blocker
i.e. bisoprolol; dosages titrated on blood pressure, ECG, heart rate
ACEi/ARB
i.e. ramipril; dosages titrated on blood pressure, ECG, heart rate
CCB
i.e. diltiazem; dosages titrated on blood pressure, ECG, heart rate
Nitrates
i.e. nitroglycerine; dosages titrated on blood pressure, ECG, heart rate
Anticoagulant
i.e. warfarin; the selection of the anticoagulant agent will be based on the clinical scenario, contraindications etc
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Centro Cardiologico Monzino
OTHER
IRCCS Policlinico S. Donato
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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MONTONE ROCCO ANTONIO
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
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, , Italy
IRCCS Policlinico San Donato
San Donato Milanese, , Italy
Countries
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References
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Jaguszewski M, Osipova J, Ghadri JR, Napp LC, Widera C, Franke J, Fijalkowski M, Nowak R, Fijalkowska M, Volkmann I, Katus HA, Wollert KC, Bauersachs J, Erne P, Luscher TF, Thum T, Templin C. A signature of circulating microRNAs differentiates takotsubo cardiomyopathy from acute myocardial infarction. Eur Heart J. 2014 Apr;35(15):999-1006. doi: 10.1093/eurheartj/eht392. Epub 2013 Sep 17.
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GR-2019-12370197
Identifier Type: -
Identifier Source: org_study_id
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