Multi-modality Imaging in Acute Myocardial Infarction

NCT02926755 | Completed DMC

• 1 other identifier: 2015-144
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myocardial Infarction; STEMI; Coronary Artery Disease; Atherosclerotic Plaque Disruption With Thrombosis of Artery

Keywords

Intra Venous Ultrasound (IVUS); Fractional Flow Reserve (FFR); Optical Coherence Tomography (OCT); Acute Myocardial Infarction; Coronary Artery Disease (CAD); Angiography

Outcome Measures

Primary Outcomes (6)

• Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured during cardiac cath

  2-40 days after the first cardiac catheterization procedure, depending on the urgency to evaluate the other arteries and the stability of the patient after the first procedure. Repeat cardiac catheterization for Data Analysis Stenosis severity (using angiographic criteria defined as Diameter Stenosis (DS) \> 70% and DS \> 50%;

  40 Days

• Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by IVUS

  Stenosis severity will be measured by IVUS criteria defined as minimal lumen cross sectional area (mCSA) \< 4mm2, mCSA \< 2.5mm2, plaque volume; and vulnerable plaque by IVUS-fibrous cap thickness.

  40 Days

• Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by FFR

  cardiac catheterization with FFR criteria defined as FFR \< 0.80;

  40 Days

• Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by OCT

  Vulnerable plaque characteristics will be measured by OCT criteria - plaque ulceration, erosion, thrombus, fibrous cap thickness

  2 - 40 Days

• Prevalence of hemodynamically-significant stenosis in non-infarct-related coronary arteries in STEMI patients as measured by CCTA

  Stenosis severity will be measured by CCTA criteria-Diameter Stenosis \>70%

  2 - 40 Days

• Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by NIRS

  Vulnerable plaque characteristics will be measure by NIRS criteria - Lipid Core Burden Index (LCBI) - 4mm \> 300, Lipid Core Containing Plaque (LCP) distribution

  2 - 40 Days

Secondary Outcomes (2)

• Incidence of cardiac events at 1-year after STEMI.

  1 Year

• Correlation with coronary angiography with imagings findings and Coronary CT Angiography (CCTA) imaging findings.

  40 Days

Study Arms (1)

Angiography to Assess Vulnerable Plaque

EXPERIMENTAL

In order to characterize plaque a repeat Coronary Angiography within 2 to 40 days will be done to assess vulnerable plaque features such as plaque tears, plaque thickness, plaque volume, and lipid content in plaque) in heart arteries in patients who have suffered a recent acute heart attack, and who have blockages \>50% in one or more of the other arteries in the heart.

Procedure: Coronary Angiography

Interventions

Coronary Angiography PROCEDURE

Coronary angiography which includes fractional flow reserve (FFR),that allows precise measurement of blood flow in the arteries to the heart; the Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about the amount of lipid and cholesterol in the plaque, and plaque volume;the Optical Coherence Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque thickness; and Coronary CT Angiography (CCTA) to evaluate plaque characteristics, and correlate with the invasive findings. The research portion of the study requires all imaging studies be performed (NIRS, IVUS, OCT, FFR) during coronary angiography, rather than just one or two of these imaging studies, and the CCTA.

Angiography to Assess Vulnerable Plaque

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beamont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (1)

• Ihdayhid AR, Tzimas G, Peterson K, Ng N, Mirza S, Maehara A, Safian RD. Diagnostic Performance of AI-enabled Plaque Quantification from Coronary CT Angiography Compared with Intravascular Ultrasound. Radiol Cardiothorac Imaging. 2024 Dec;6(6):e230312. doi: 10.1148/ryct.230312.

  PMID: 39540820 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Robert Safian, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: October 6, 2016
• Study Start: January 20, 2016
• Primary Completion: February 11, 2019
• Study Completion: February 11, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)