DEFINing the PrEvalence and Characteristics of Coronary Artery Disease Among Patients With TYPE 2 Myocardial Infarction Using CT-FFR

NCT04864119 | Completed

• 1 other identifier: 2021P000435
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of this study include:

• determine the prevalence of coronary artery disease among patients with type 2 myocardial infarction
• determine the prevalence of hemodynamically significant stenosis among patients with type 2 myocardial infarction The investigators hypothesize that patients with type 2 myocardial infarction will have a high burden of coronary artery plaque and a high prevalence of obstructive coronary artery disease with hemodynamic significance.

Conditions

Type 2 Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• Prevalence of obstructive coronary artery disease

  (defined as a stenosis of greater or equal to 70% in any epicardial vessel except left main coronary artery where greater or equal to 50% will be considered obstructive)

  1 year

• Prevalence of hemodynamically significant stenosis

  as determined by FFR \<0.8

  1 year

Secondary Outcomes (6)

• Prevalence of non-calcified coronary plaque

  1 year

• Prevalence of high-risk plaque features

  1 year

• Prevalence of any coronary plaque

  1 year

• Prevalence of calcified coronary plaque

  1 year

• Number of obstructive stenosis in coronary arteries

  1 year

Eligibility Criteria

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

Study Population

This is a single-center prospective observational study that will enroll 50 adult patients who are admitted with a type 2 myocardial infarction at Massachusetts General Hospital.

You may qualify if:

• Capable of giving informed consent
• Patients aged greater than18 years diagnosed with type 2 MI, defined based on the 4th Universal Definition of Myocardial Infarction (1), during their index hospitalization
• Type 2 MI will be defined as detection of a rise and/or fall of troponin levels with at least one value above the 99th percentile and evidence of an imbalance between myocardial oxygen supply and demand, requiring at least one of the following:
• Symptoms of acute myocardial ischemia;
• New ischemic ECG changes;
• Development of pathological Q waves;
• Imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
• Patients with medical precipitants of their type 2 MI or post-operative type 2 MI. A minimum of 10 patients with post-operative type 2 MI will be included to ensure a diverse clinical patient population is enrolled.

You may not qualify if:

• Other types of MI
• Hemodynamic instability
• eGFR \<30 ml/min/1.73m2
• Pregnant or breast-feeding women
• Contrast allergy
• Pre-operative history of MI, coronary angiography or coronary revascularization for patients with post-operative type 2 MI
• Severe arrhythmias precluding optimal CT image acquisition
• Prior coronary artery bypass grafting
• Known prior left main coronary artery PCI
• Known PCI of the left coronary system combined with \>30% stenosis in the left main artery
• Known prior PCI to 2 or more major coronary vessels (i.e. left anterior descending artery, left circumflex artery, right coronary artery)
• Allergy or contraindication to nitroglycerin

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• HeartFlow, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Lin C, McCarthy CP, Mohebi R, Liu Y, Blankstein R, Murphy SP, Miksenas H, Rogers C, Amponsah DK, Rambarat PK, Raghavan A, Levin A, Ghoshhajra B, Wasfy JH, Hedgire S, Januzzi JL Jr. Sex Differences in Coronary Artery Disease Characteristics Among Patients With Type 2 Myocardial Infarction. JACC Adv. 2023 Dec 22;3(2):100795. doi: 10.1016/j.jacadv.2023.100795. eCollection 2024 Feb.

  PMID: 38939381 DERIVED

• McCarthy CP, Murphy SP, Amponsah DK, Rambarat PK, Lin C, Liu Y, Mohebi R, Levin A, Raghavan A, Miksenas H, Rogers C, Wasfy JH, Blankstein R, Ghoshhajra B, Hedgire S, Januzzi JL Jr. Coronary Computed Tomographic Angiography With Fractional Flow Reserve in Patients With Type 2 Myocardial Infarction. J Am Coll Cardiol. 2023 Oct 24;82(17):1676-1687. doi: 10.1016/j.jacc.2023.08.020. Epub 2023 Sep 29.

  PMID: 37777947 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Samples

Study Officials

• James L Januzzi, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 28, 2021
• Study Start: April 11, 2021
• Primary Completion: February 3, 2023
• Study Completion: March 11, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

US (1)