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Neuroinflammation After Myocardial Infarction - Imaging Substudy

Neuroinflammation After Myocardial Infarction - Imaging Substudy

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03968445
Enrollment
6
Registered
2019-05-30
Start date
2019-10-17
Completion date
2026-08-17
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Brief summary

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.

Detailed 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.

Interventions

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

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

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
TPSO-PET measurement of neuroinflammation after acute myocardial infarction2 yearsThe regional brain concentrations of \[F-18\]DPA-714, a PET imaging marker of neuroinflammation, will be compared between study participants who have recently been hospitalized for acute myocardial infarction (AMI) and a control group undergoing elective percutaneous coronary interventions (PCI).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026