Neuroinflammation After Myocardial Infarction - Imaging Substudy
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2019
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedStudy Start
First participant enrolled
October 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
December 11, 2025
December 1, 2025
9 years
May 16, 2019
December 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
TPSO-PET measurement of neuroinflammation after acute myocardial infarction
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).
2 years
Study Arms (2)
Recent Myocardial Infarction
EXPERIMENTALundergoing elective percutaneous coronary intervention
EXPERIMENTALInterventions
\[18F\]DPA-714-PET/MRI
Eligibility Criteria
You may qualify if:
- Participation in UAB IRB protocol "Neuroinflammation After Acute Myocardial Infarction" (IRB-300002751, PI Lazar).
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics
Study Record Dates
First Submitted
May 16, 2019
First Posted
May 30, 2019
Study Start
October 17, 2019
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
December 11, 2025
Record last verified: 2025-12