NCT01059214

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
455

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2010

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2012

Completed
Last Updated

September 13, 2019

Status Verified

October 11, 2012

First QC Date

January 28, 2010

Last Update Submit

September 12, 2019

Conditions

Acute Myocardial InfarctionCoronary Artery DiseaseMyocardial FibrosisGadoliniumMyocardial Edema

Keywords

Acute Myocardial InfarctionReperfusionMRIHeart Attack

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Frank JA, Mattay VS, Duyn J, Sobering G, Barrios FA, Zigun J, Sexton R, Kwok P, Woo J, Moonen C, et al. Measurement of relative cerebral blood volume changes with visual stimulation by 'double-dose' gadopentetate-dimeglumine-enhanced dynamic magnetic resonance imaging. Invest Radiol. 1994 Jun;29 Suppl 2:S157-60. doi: 10.1097/00004424-199406001-00052. No abstract available.

    PMID: 7928216BACKGROUND

  • Mattay VS, Weinberger DR, Barrios FA, Sobering GS, Kotrla KJ, van Gelderen P, Duyn JH, Sexton RH, Moonen CT, Frank JA. Brain mapping with functional MR imaging: comparison of gradient-echo--based exogenous and endogenous contrast techniques. Radiology. 1995 Mar;194(3):687-91. doi: 10.1148/radiology.194.3.7862963.

    PMID: 7862963BACKGROUND

  • Deo A, Fogel M, Cowper SE. Nephrogenic systemic fibrosis: a population study examining the relationship of disease development to gadolinium exposure. Clin J Am Soc Nephrol. 2007 Mar;2(2):264-7. doi: 10.2215/CJN.03921106. Epub 2007 Feb 7.

    PMID: 17699423BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Andrew E Arai, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

January 28, 2010

First Posted

January 29, 2010

Study Start

December 10, 2009

Study Completion

October 11, 2012

Last Updated

September 13, 2019

Record last verified: 2012-10-11

Locations

US(1)