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Neuroinflammation After Myocardial Infarction - Imaging Substudy

Primary Purpose

Myocardial Infarction

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]DPA-714-PET/MRI
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Recent Myocardial Infarction

undergoing elective percutaneous coronary intervention

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
May 16, 2019
Last Updated
August 18, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03968445
Brief Title
Neuroinflammation After Myocardial Infarction - Imaging Substudy
Official Title
Neuroinflammation After Myocardial Infarction - Imaging Substudy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
October 24, 2024 (Anticipated)
Study Completion Date
July 24, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recent Myocardial Infarction
Arm Type
Experimental
Arm Title
undergoing elective percutaneous coronary intervention
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[18F]DPA-714-PET/MRI
Intervention Description
[18F]DPA-714-PET/MRI
Primary Outcome Measure Information:
Title
TPSO-PET measurement of neuroinflammation after acute myocardial infarction
Description
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).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan McConathy, MD, PhD
Phone
205-996-7115
Email
jmcconathy@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
April Riddle, BS RT
Phone
205-934-6504
Email
ariddle@uabmc.edu
Facility Information:
Facility Name
University of Alabama at Birmingham Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD
Phone
205-996-7115
Email
jmcconathy@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bag Asim, MD
First Name & Middle Initial & Last Name & Degree
Bhambhvani Pradeep, MD
First Name & Middle Initial & Last Name & Degree
Choudhary Gagandeep, MD
First Name & Middle Initial & Last Name & Degree
Geldmacher David, MD
First Name & Middle Initial & Last Name & Degree
Lapi Suzanne, PhD
First Name & Middle Initial & Last Name & Degree
Jeffers Charlotte Denise, RPh
First Name & Middle Initial & Last Name & Degree
Natelson Marissa, MD
First Name & Middle Initial & Last Name & Degree
Roberson Erik, MD, PhD

12. IPD Sharing Statement

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Neuroinflammation After Myocardial Infarction - Imaging Substudy

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