Cardiac MRI for Patients Enrolled in INFUSE-AMI

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01059214
First received: January 28, 2010
Last updated: January 14, 2014
Last verified: October 2012
  Purpose

Background:

  • INFUSE AMI is an ongoing clinical trial examining how patients with heart attacks are treated. The study's aim is to help determine the best way to treat patients with specific kinds of heart attacks caused by blood clots.
  • To evaluate the effect of the heart attack on the heart tissue and function, participants in the INFUSE-AMI study will have magnetic resonance imaging (MRI) scans of the heart at specific times after their heart attack.

Objectives:

- To perform cardiac MRI scans on patients who are participating in the INFUSE-AMI study.

Eligibility:

- Individuals at least 18 years of age who are enrolled in the INFUSE-AMI study.

Design:

  • Participants will have an MRI scan of the heart about 5 days and between 23 and 44 days after their heart attack. The MRI scan at day 5 is optional.
  • Participants will provide a blood sample prior to the MRI scan.
  • During the scan, participants will be given a contrast drug to show the blood flow to and within the heart. An electrocardiogram will be used to monitor the heart during the procedure.
  • No other treatment will be provided in this protocol.

Condition
Acute Myocardial Infarction
Coronary Artery Disease
Myocardial Fibrosis
Gadolinium
Myocardial Edema

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cardiac MRI for Patients Enrolled in INFUSE-AMI

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 3
Study Start Date: December 2009
Estimated Study Completion Date: October 2012
Detailed Description:

The purpose of this research protocol is to perform contrast enhanced cardiac MRI studies on patients enrolled in the INFUSE-AMI study (INFUSE-AMI is a multicenter, open-label controlled single-blind randomized study with up to 452 patients enrolled in approximately 50 US and European sites). Patients who present with anterior ST elevation myocardial infarction by electrocardiogram (STEMI) and an occluded proximal or mid left anterior descending artery (LAD) with TIMI 0/1 flow will be eligible for randomization to one of the following arms: 1) Local infusion of Abciximab and thrombus aspiration, 2) Local infusion of Abciximab and no thrombus aspiration, 3) No local infusion and thrombus aspiration, or 4) No local infusion and no thrombus aspiration. Cardiac MRI is performed to assess left ventricular function and infarct size for the primary INFUSE-AMI study. Thus, this local research protocol will provide the cardiac MRI scans at no cost to the participant. Additional images of the heart will be obtained for local research purposes. Cardiac MRI scans will be performed at around 5 days (optional) and at 30 days after myocardial infarction.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

-INCLUSION CRITERIA:

i. Signed consent for INFUSE-AMI

ii. Ability to travel to the NIH for participation in MRI studies. and

iii. Ability to provide informed consent, or holds a valid surrogate decision maker authorization (such as Durable Power of Attorney).

EXCLUSION CRITERIA:

i. Known hypersensitivity or contraindication to gadolinium contrast

ii. Severe kidney disease (eGFR < 30 mLIminIl .73 m(2) BSA)

iii. Pregnancy

iv. Breast feeding (unless subject is willing to discard breast milk for 24 hours)

v. Cardiac pacemaker or implantable defibrillator

vi. Non-MRI compatible aneurysm clip

vii. Neural stimulator (e.g. TENS unit)

viii. Any implanted or magnetically activated device (e.g. insulin pump)

ix. Any type of non-MRI compatible metallic ear implant

x. Metal shavings in the orbits

xi. Any metallic or foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059214

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Suburban Hospital
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
Investigators
Principal Investigator: Andrew E Arai, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01059214     History of Changes
Other Study ID Numbers: 100034, 10-H-0034
Study First Received: January 28, 2010
Last Updated: January 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Acute Myocardial Infarction
Reperfusion
MRI
Heart Attack

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Edema
Fibrosis
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Signs and Symptoms
Pathologic Processes
Ischemia
Necrosis

ClinicalTrials.gov processed this record on August 28, 2014