Neuroinflammation After Myocardial Infarction - Imaging Substudy

Myocardial Infarction Clinical Trial

Official title:

Neuroinflammation After Myocardial Infarction - Imaging Substudy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03968445
• Other study ID #: IRB-300003221 R19-045
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 17, 2019
• Est. completion date: July 24, 2025

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: July 24, 2025
• Est. primary completion date: October 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Medical Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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