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: October 9, 2014
Last verified: October 2012

January 28, 2010
October 9, 2014
December 2009
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Complete list of historical versions of study NCT01059214 on ClinicalTrials.gov Archive Site
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Cardiac MRI for Patients Enrolled in INFUSE-AMI
Cardiac MRI for Patients Enrolled in INFUSE-AMI

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.

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.

Observational
Time Perspective: Prospective
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  • Acute Myocardial Infarction
  • Coronary Artery Disease
  • Myocardial Fibrosis
  • Gadolinium
  • Myocardial Edema
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
October 2012
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-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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01059214
100034, 10-H-0034
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National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Andrew E Arai, M.D. National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health Clinical Center (CC)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP