Multi-modality Imaging in Acute Myocardial Infarction

Completed · Not applicable

Conditions studied: Acute Myocardial Infarction, STEMI, Coronary Artery Disease, Atherosclerotic Plaque Disruption With Thrombosis of Artery

In brief

The goal of this study is to use three (3) different imaging techniques:Fractional Flow Reserve (FFR) allows precise measurement of blood flow in the arteries to the heart, and is more reliable than pictures alone to determine the significance of blockages in the heart; Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about the amount of lipid and cholesterol in the plaque, and plaque volume; and Optical Coherence Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque thickness; to evaluate high risk non-infarct-related coronary lesion in patients who have suffered a recent heart attack, underwent successful opening of the artery with a stent, and have blockages greater than or equal to 50% in one or more of the other arteries to the heart; and to correlate this findings with cardiovascular outcomes at 1 year.

Key facts

Study ID

NCT02926755

Run by

Corewell Health East

People needed

62

Starts

2016-01-20

Expected to finish

2019-02-11

Last updated by the study team

2019-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients with ST-elevation acute myocardial infarction (STEMI) and age > 18 years who meet all of the following criteria:
• Successful primary Percutaneous Intervention (PCI) of the Infarcted Related Artery (IRA) defined as final stenosis < 30%, Thrombolysis In Myocardial Infarction (TIMI) 3 flow
• At least 1 non-IRA with diameter stenosis ≥ 50% and reference vessel diameter > 2mm
• None of the exclusion criteria

You may not qualify if…

• Patients will be excluded if any of the following are present:
• Cardiogenic shock that persists > 24 hours after primary PCI
• Diffuse disease in non-IRA that precludes successful stenting
• Estimated Glomerular Filtration Rate (eGFR) < 30 cc/min/1.73 m2 after hydration or optimization of Congestive Heart Failure (CHF) for cardiac death
• eGFR <60 cc/min/1.73 m2, will be in the MIAMI study for invasive imaging treatment group/cohort but will not get the coronary CCTA
• eGFR < 60 cc/min/1.73 m2, for coronary CCTA
• Active bleeding as defined as a fall in hemoglobin (HGB) concentration > 3 g/dL within 24 hours requiring blood transfusion, vasopressors to maintain Systolic BP > 100mmhg, or emergency surgical, endovascular, or endoscopic intervention.
• Mechanical complication of MI such as severe Mitral-Valve Regurgitation (MR), Ventricular Septal Defect (VSD) or pulmonary edema
• Uncontrolled Ventricular Tachycardia (VT) after primary PCI
• Inability to provide informed consent
• Ventilator-dependent respiratory failure
• Only non-IRA is a chronic total occlusion
• Non-IRA is in a Saphenous Vein Graft (SVG) or arterial graft
• Non-IRA is in the left main, ostial Left Anterior Descending (LAD), or ostial Left circumflex (LCX)
• Non-IRA includes a bifurcation with side branch > 2mm, medina 1-1-1
• Need for multivessel primary PCI during the index procedure

Where it is running

• William Beamont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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