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Clinical Trials/NCT03968445
NCT03968445
Active, not recruiting
Phase 1

Neuroinflammation After Myocardial Infarction - Imaging Substudy

University of Alabama at Birmingham1 site in 1 country6 target enrollmentOctober 17, 2019

Overview

Phase
Phase 1
Intervention
[18F]DPA-714-PET/MRI
Conditions
Myocardial Infarction
Sponsor
University of Alabama at Birmingham
Enrollment
6
Locations
1
Primary Endpoint
TPSO-PET measurement of neuroinflammation after acute myocardial infarction
Status
Active, not recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 17, 2019
End Date
October 1, 2028
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jonathan E McConathy

M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • Participation in UAB IRB protocol "Neuroinflammation After Acute Myocardial Infarction" (IRB-300002751, PI Lazar).
  • 21 years of age or older
  • . English speaking with at least 8th grade education
  • High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs
  • 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

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

Arms & Interventions

Recent Myocardial Infarction

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

undergoing elective percutaneous coronary intervention

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

Outcomes

Primary Outcomes

TPSO-PET measurement of neuroinflammation after acute myocardial infarction

Time Frame: 2 years

The 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).

Study Sites (1)

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