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Evaluation of CCR2 in Patients Post Myocardial Infarction

Primary Purpose

Heart Diseases

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
64Cu-DOTA-ECL1i
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Diseases

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy Volunteers:
  2. Age 21 to 80 years of either sex, any race
  3. Capable of lying still and supine within the PET/CT and PET/MR scanner for 1 hour and follow instructions for breathing protocol during the CT portion
  4. No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year
  5. No known history of cardiac. pulmonary, hepatic, or renal disease or diabetes
  6. No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions
  7. Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol.

Inflammatory Heart Disease

  1. Age 21 to 80 years of either sex, any race who have suffered a STEMI within the past 6 months as well as other forms of inflammatory heart disease including sarcoidosis, myocarditis, cardiomyopathy, injected cardiovascular implantable electronic devices pacemakers/LVAD
  2. Are clinically stable to undergo imaging with either PET/MR or PET/CT.
  3. Capacity to give written informed consent and ability to follow study procedures
  4. Pre-menopausal women must have a negative urine pregnancy test within 24 hours prior to the administration of 64-Cu-DOTA-ECL1i.

Exclusion Criteria:

Healthy volunteers:

  1. Currently enrolled in another study using an investigational drug
  2. Angina
  3. Uncontrolled heart failure
  4. uncontrolled hypertension baseline hypotension below 90/50
  5. Has any condition that in the opinion of the PI or designee that could increase risk to the subject
  6. Is deemed likely to be unable to perform all research procedures
  7. Have contraindications to PET/CT imaging like claustrophobia
  8. Have contraindication to gadolinium
  9. Pregnant or breastfeeding
  10. Currently using recreational drubs
  11. Body weight of more than 300 lbs
  12. Active symptoms or history of cardiac, pulmonary, hepatic or renal disease or diabetes
  13. currently taking any prescription medications
  14. Presence of an implanted device incompatible with CT or MRI scanning Inflammatory Heart Disease

1) Clinically unstable including post MI angina, uncontrolled heart failure, sever hypertension, hypotension AV block 2) Has any condition that in the opinion of the PI could increase risk to the subject 3) Claustrophobia 4) contraindication to gadolinium contrast 5) Pregnant 6) Currently using recreational drugs 7) Body Weight more than 300 lbs 8) Currently enrolled in another study

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Post ST Elevation Myocardial Infarction/ Heart Attack

Sarcoidosis

Myocarditis

Cardiomyopathy

Infected Cardiovascular Implantable Electronic Devices

Healthy Volunteers

Arm Description

Image patients who have had a heart attack

Image patients who have Sarcoidosis

Image patients with Myocarditis

Image patients with cardiomyopathy

Image patients with cardiovascular implanted medical devices

Image healthy volunteers

Outcomes

Primary Outcome Measures

Number of participants who have heart disease as shown in the images
PET images will be reconstruction using an iterative algorithm that incorporates resolution recovery, and will be corrected for attenuation using their respective CT or MR data sets

Secondary Outcome Measures

Full Information

First Posted
October 7, 2021
Last Updated
November 22, 2022
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05107596
Brief Title
Evaluation of CCR2 in Patients Post Myocardial Infarction
Official Title
Preliminary Evaluation of 64Cu-DOTA-ECL1i in Patients Post-ST-Elevation Myocardial Infarction(STEMI)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2018 (Actual)
Primary Completion Date
November 24, 2025 (Anticipated)
Study Completion Date
November 24, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

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

5. Study Description

Brief Summary
To determine the feasibility of 64Cu-DOTA-ECL1i, an investigational PET imaging drug, at the cellular level in the myocardium for individuals who have suffered a heart attack or who have other inflammatory heart disease.
Detailed Description
To determine the feasibility of 64Cu-DOTA-ECL1i to detect CCR2+monocytes and macrophages which are cells that are responsible for protecting tissues from foreign substances in the myocardium by PET/MR and PET/CT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Post ST Elevation Myocardial Infarction/ Heart Attack
Arm Type
Active Comparator
Arm Description
Image patients who have had a heart attack
Arm Title
Sarcoidosis
Arm Type
Active Comparator
Arm Description
Image patients who have Sarcoidosis
Arm Title
Myocarditis
Arm Type
Active Comparator
Arm Description
Image patients with Myocarditis
Arm Title
Cardiomyopathy
Arm Type
Active Comparator
Arm Description
Image patients with cardiomyopathy
Arm Title
Infected Cardiovascular Implantable Electronic Devices
Arm Type
Active Comparator
Arm Description
Image patients with cardiovascular implanted medical devices
Arm Title
Healthy Volunteers
Arm Type
Active Comparator
Arm Description
Image healthy volunteers
Intervention Type
Drug
Intervention Name(s)
64Cu-DOTA-ECL1i
Other Intervention Name(s)
Imaging drug
Intervention Description
Inject PET Radioisotope for imaging
Primary Outcome Measure Information:
Title
Number of participants who have heart disease as shown in the images
Description
PET images will be reconstruction using an iterative algorithm that incorporates resolution recovery, and will be corrected for attenuation using their respective CT or MR data sets
Time Frame
1 or 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Volunteers: Age 21 to 80 years of either sex, any race Capable of lying still and supine within the PET/CT and PET/MR scanner for 1 hour and follow instructions for breathing protocol during the CT portion No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year No known history of cardiac. pulmonary, hepatic, or renal disease or diabetes No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol. Inflammatory Heart Disease Age 21 to 80 years of either sex, any race who have suffered a STEMI within the past 6 months as well as other forms of inflammatory heart disease including sarcoidosis, myocarditis, cardiomyopathy, injected cardiovascular implantable electronic devices pacemakers/LVAD Are clinically stable to undergo imaging with either PET/MR or PET/CT. Capacity to give written informed consent and ability to follow study procedures Pre-menopausal women must have a negative urine pregnancy test within 24 hours prior to the administration of 64-Cu-DOTA-ECL1i. Exclusion Criteria: Healthy volunteers: Currently enrolled in another study using an investigational drug Angina Uncontrolled heart failure uncontrolled hypertension baseline hypotension below 90/50 Has any condition that in the opinion of the PI or designee that could increase risk to the subject Is deemed likely to be unable to perform all research procedures Have contraindications to PET/CT imaging like claustrophobia Have contraindication to gadolinium Pregnant or breastfeeding Currently using recreational drubs Body weight of more than 300 lbs Active symptoms or history of cardiac, pulmonary, hepatic or renal disease or diabetes currently taking any prescription medications Presence of an implanted device incompatible with CT or MRI scanning Inflammatory Heart Disease 1) Clinically unstable including post MI angina, uncontrolled heart failure, sever hypertension, hypotension AV block 2) Has any condition that in the opinion of the PI could increase risk to the subject 3) Claustrophobia 4) contraindication to gadolinium contrast 5) Pregnant 6) Currently using recreational drugs 7) Body Weight more than 300 lbs 8) Currently enrolled in another study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kitty D Harrison, BSN, RN
Phone
314-747-0183
Email
kittydharrison@wustl.edu
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kitty Harrison
Phone
314-747-0183
Email
harrisonk@mir.wustl.edu

12. IPD Sharing Statement

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Evaluation of CCR2 in Patients Post Myocardial Infarction

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