Neuroinflammation After Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-17

Study Completion Date

2028-10-31

Brief Summary

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The purpose of the study is to see if positron emission tomography and magnetic resonance imaging (PET/MRI) with an investigational drug called \[18F\]DPA-714 will show inflammation in the brain after a heart attack. This study may help physicians and researchers better understand the role of brain inflammation in heart disease and develop new treatments to protect the brain.

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Detailed Description

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The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET ligand \[18F\]DPA-714 in individuals with recent AMI. The basic premise is that AMI leads to systemic inflammation that includes inflammation in the brain. The PET tracer \[18F\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The estimates of brain TSPO binding in patients with recent AMI will be compared to a matched group of patients who have undergone a recent elective PCI procedure.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Recent Myocardial Infarction

Group Type EXPERIMENTAL

[18F]DPA-714-PET/MRI

Intervention Type DRUG

\[18F\]DPA-714-PET/MRI

undergoing elective percutaneous coronary intervention

Group Type EXPERIMENTAL

[18F]DPA-714-PET/MRI

Intervention Type DRUG

\[18F\]DPA-714-PET/MRI

Interventions

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[18F]DPA-714-PET/MRI

\[18F\]DPA-714-PET/MRI

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Participation in UAB IRB protocol "Neuroinflammation After Acute Myocardial Infarction" (IRB-300002751, PI Lazar).
2. 21 years of age or older
3. . English speaking with at least 8th grade education
4. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
5. Admission to UAB Hospital for ST-elevation acute myocardial infarction (AMI) and treatment with percutaneous coronary intervention (PCI) OR Undergoing elective percutaneous coronary intervention (PCI)

Exclusion Criteria

1. Contraindication to MRI
2. Pregnancy
3. Lactation
4. Serious medical co-morbidity that may interfere with participation
5. Prior myocardial infarction
6. Severe anemia
7. Prior coronary artery bypass grafting
8. Prior angioplasty and/or coronary artery stent placement (PCI group only)
9. History of traumatic head injury defined by a loss of consciousness ≥30 minutes or seizure at the time of injury
10. Diagnosis of major depression
11. Diagnosis of dementia
12. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No