Recruiting
Phase 1

CCR2

Sponsor:

Washington University School of Medicine

Code:

NCT05107596

Conditions

Heart Diseases

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

64Cu-DOTA-ECL1i

Study Details

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.

Conditions

Heart Diseases

Study ID

NCT05107596

Start date

Nov 24, 2018

Status verified date

Nov, 2022

Completion date

Nov 24, 2025

Anticipated

Primary completion date

Nov 24, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Post ST Elevation Myocardial Infarction/ Heart Attack

Image patients who have had a heart attack

active comparator: Sarcoidosis

Image patients who have Sarcoidosis

active comparator: Myocarditis

Image patients with Myocarditis

active comparator: Cardiomyopathy

Image patients with cardiomyopathy

active comparator: Infected Cardiovascular Implantable Electronic Devices

Image patients with cardiovascular implanted medical devices

active comparator: Healthy Volunteers

Image healthy volunteers

Interventions

64Cu-DOTA-ECL1i

Inject PET Radioisotope for imaging

Primary outcome measure

  • Number of participants who have heart disease as shown in the images [ Time Frame: 1 or 2 days ]

Central Contacts and Locations

Central contacts

Kitty D Harrison, BSN, RN

314-747-0183kittydharrison@wustl.edu

Locations

Washington University School of Medicine

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

More Information

Sponsor

Washington University School of Medicine

Last update posted

Nov 23, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2022-11-23.