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

NCT05122780 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: GR-2019-12370197
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Myocardial Infarction With Non-Obstructive Coronary Arteries

Keywords

MINOCA; coronary spasm; OCT

Outcome Measures

Primary Outcomes (2)

• 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.

  1-year follow-up

• eattle Angina Questionnaire (SAQ)

  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.

  1-year follow-up

Secondary Outcomes (15)

• Rates of major adverse cardiovascular events

  1-year follow-up

• Healthcare primary related-costs

  1-year follow-up

• Healthcare secondary related-costs

  1-year follow-up

• Healthcare secondary related-costs

  1-year follow-up

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

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

Study Arms (2)

"Precision medicine approach"

ACTIVE COMPARATOR

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).

Procedure: Coronary angiography; Diagnostic Test: OCT imaging; Procedure: Percutaneous coronary intervention (PCI):; Diagnostic Test: Acetylcholine provocative test; Diagnostic Test: TT-Echocardiography; Diagnostic Test: TE/contrast echocardiography; Diagnostic Test: Cardiac magnetic resonance; Diagnostic Test: Circulating biomarkers; Drug: Antiplatelet Drug; Drug: Statin; Drug: Beta blocker; Drug: ACEi/ARB; Drug: CCB; Drug: Nitrates; Drug: Anticoagulant

"Standard approach"

OTHER

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).

Procedure: Coronary angiography; Diagnostic Test: TT-Echocardiography; Diagnostic Test: Cardiac magnetic resonance; Drug: Antiplatelet Drug; Drug: Statin; Drug: Beta blocker; Drug: ACEi/ARB

Interventions

Coronary angiography 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

"Precision medicine approach"; "Standard approach"

OCT imaging 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.

"Precision medicine approach"

Percutaneous coronary intervention (PCI): PROCEDURE

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

"Precision medicine approach"

Acetylcholine provocative test 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).

"Precision medicine approach"

TT-Echocardiography 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.

"Precision medicine approach"; "Standard approach"

TE/contrast echocardiography 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.

"Precision medicine approach"

Cardiac magnetic resonance 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).

"Precision medicine approach"; "Standard approach"

Circulating biomarkers 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).

"Precision medicine approach"

Antiplatelet Drug 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).

"Precision medicine approach"; "Standard approach"

Statin DRUG

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

"Precision medicine approach"; "Standard approach"

Beta blocker DRUG

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

"Precision medicine approach"; "Standard approach"

ACEi/ARB DRUG

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

"Precision medicine approach"; "Standard approach"

CCB DRUG

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

"Precision medicine approach"

Nitrates DRUG

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

"Precision medicine approach"

Anticoagulant DRUG

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

"Precision medicine approach"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Centro Cardiologico Monzino: collaborator
• IRCCS Policlinico S. Donato: collaborator

Study Sites (3)

Centro Cardiologico Monzino

Milan, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, 20097, Italy

Location

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MeSH Terms

Conditions

MINOCA; Angina Pectoris, Variant

Interventions

Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Adrenergic beta-Antagonists; Nitrates; Anticoagulants

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina, Unstable; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals

Study Officials

• Nicola Cosentino, MD

  Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

• Riccardo Gorla, MD

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: November 17, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)