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Trial record 2 of 60 for:    Recruiting Studies | Heart Attack | United States

Neuroinflammation After Myocardial Infarction - Imaging Substudy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03968445
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan E McConathy, University of Alabama at Birmingham

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 24, 2019
Estimated Primary Completion Date : July 24, 2021
Estimated Study Completion Date : July 24, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participation in UAB IRB protocol "Neuroinflammation After Acute Myocardial Infarction" (IRB-300002751, PI Lazar).
  2. 50 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968445


Contacts
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Contact: Jonathan McConathy, MD, PhD 205-996-7115 jmcconathy@uabmc.edu
Contact: April Riddle, BS RT 205-934-6504 ariddle@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Medical Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jonathan McConathy, MD    205-996-7115    jmcconathy@uabmc.edu   
Principal Investigator: Jonathan McConathy, MD, PhD         
Sub-Investigator: Bag Asim, MD         
Sub-Investigator: Bhambhvani Pradeep, MD         
Sub-Investigator: Choudhary Gagandeep, MD         
Sub-Investigator: Geldmacher David, MD         
Sub-Investigator: Lapi Suzanne, PhD         
Sub-Investigator: Jeffers Charlotte Denise, RPh         
Sub-Investigator: Natelson Marissa, MD         
Sub-Investigator: Roberson Erik, MD, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham

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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    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases