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出境医 / 临床实验 / Neuroinflammation After Myocardial Infarction - Imaging Substudy

Neuroinflammation After Myocardial Infarction - Imaging Substudy

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
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.
Study Design
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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
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 [ 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).


Eligibility Criteria
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Ages Eligible for Study:   21 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. 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

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
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date September 3, 2020
Actual Study Start Date  ICMJE July 24, 2019
Estimated Primary Completion Date July 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019) 		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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroinflammation After Myocardial Infarction - Imaging Substudy
Official Title  ICMJE Neuroinflammation After Myocardial Infarction - Imaging Substudy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE Drug: [18F]DPA-714-PET/MRI
[18F]DPA-714-PET/MRI
Study Arms  ICMJE
  • Experimental: Recent Myocardial Infarction
    Intervention: Drug: [18F]DPA-714-PET/MRI
  • Experimental: undergoing elective percutaneous coronary intervention
    Intervention: Drug: [18F]DPA-714-PET/MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 24, 2021
Estimated Primary Completion Date July 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jonathan McConathy, MD, PhD 205-996-7115 jmcconathy@uabmc.edu
Contact: April Riddle, BS RT 205-934-6504 ariddle@uabmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03968445
Other Study ID Numbers  ICMJE IRB-300003221 R19-045
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonathan E McConathy, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alabama at Birmingham
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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