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Neuroinflammation After Myocardial Infarction - Imaging Substudy

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT03968445
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
57.2
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Neuroinflammation After Myocardial Infarction - Imaging Substudy
Actual Study Start Date :
Oct 17, 2019
Anticipated Primary Completion Date :
Oct 24, 2023
Anticipated Study Completion Date :
Jul 24, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Recent Myocardial Infarction

Drug: [18F]DPA-714-PET/MRI
[18F]DPA-714-PET/MRI
Experimental: undergoing elective percutaneous coronary intervention

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

Outcome Measures

Primary Outcome Measures

  1. TPSO-PET measurement of neuroinflammation after acute myocardial infarction [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Medical Center Birmingham Alabama United States 35294

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jonathan E McConathy, M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT03968445
Other Study ID Numbers:
  • IRB-300003221 R19-045
First Posted:
May 30, 2019
Last Update Posted:
Aug 30, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myocardial Infarction
Infarction

Study Results

No Results Posted as of Aug 30, 2021