Study: NCT05122780

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Coronary angiography
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: PROCEDURE
Group type: OTHER
Intervention: Coronary angiography
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
Group type: ACTIVE_COMPARATOR
Intervention: OCT imaging
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
Group type: ACTIVE_COMPARATOR
Intervention: Percutaneous coronary intervention (PCI):
Description: PCI with stent implantation will be considered in selected cases with evidences of plaque rupture

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Acetylcholine provocative test
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
Group type: ACTIVE_COMPARATOR
Intervention: TT-Echocardiography
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
Group type: OTHER
Intervention: TT-Echocardiography
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
Group type: ACTIVE_COMPARATOR
Intervention: TE/contrast echocardiography
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
Group type: ACTIVE_COMPARATOR
Intervention: Cardiac magnetic resonance
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
Group type: OTHER
Intervention: Cardiac magnetic resonance
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
Group type: ACTIVE_COMPARATOR
Intervention: Circulating biomarkers
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
Group type: ACTIVE_COMPARATOR
Intervention: Antiplatelet Drug
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
Group type: OTHER
Intervention: Antiplatelet Drug
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
Group type: ACTIVE_COMPARATOR
Intervention: Statin
Description: i.e. atorvastatin; dosages titrated on the patient's clinical characteristics

Intervention type: DRUG
Group type: OTHER
Intervention: Statin
Description: i.e. atorvastatin; dosages titrated on the patient's clinical characteristics

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Beta blocker
Description: i.e. bisoprolol; dosages titrated on blood pressure, ECG, heart rate

Intervention type: DRUG
Group type: OTHER
Intervention: Beta blocker
Description: i.e. bisoprolol; dosages titrated on blood pressure, ECG, heart rate

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: ACEi/ARB
Description: i.e. ramipril; dosages titrated on blood pressure, ECG, heart rate

Intervention type: DRUG
Group type: OTHER
Intervention: ACEi/ARB
Description: i.e. ramipril; dosages titrated on blood pressure, ECG, heart rate

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: CCB
Description: i.e. diltiazem; dosages titrated on blood pressure, ECG, heart rate

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nitrates
Description: i.e. nitroglycerine; dosages titrated on blood pressure, ECG, heart rate

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Anticoagulant
Description: i.e. warfarin; the selection of the anticoagulant agent will be based on the clinical scenario, contraindications etc