Neuroinflammation After Myocardial Infarction - Imaging Substudy

The University of Alabama at Birmingham

Status and phase: Active, not recruiting; Phase 1

Conditions: Myocardial Infarction

Treatments: Drug: [18F]DPA-714-PET/MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03968445

IRB-300003221 R19-045

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Recent Myocardial Infarction

Experimental group

Treatment:

Drug: [18F]DPA-714-PET/MRI

undergoing elective percutaneous coronary intervention

Experimental group

Treatment:

Drug: [18F]DPA-714-PET/MRI