Cardiac MRI for Patients Enrolled in INFUSE-AMI
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | December 10, 2009 |
| End Date: | October 11, 2012 |
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.
- 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.
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.
-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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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