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Active, Not Recruiting

NCT Number: NCT03968445

Neuroinflammation After Myocardial Infarction - Imaging Substudy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) rs6971.
  • 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
  • Pregnancy
  • Lactation
  • 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.

Treatment and study plan

[18F]DPA-714-PET/MRI

Drug

[18F]DPA-714-PET/MRI

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
May 30, 2019
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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