Evaluation of CCR2 in Patients Post Myocardial Infarction

NCT05107596 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 201807140
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  1 or 2 days

Study Arms (6)

Post ST Elevation Myocardial Infarction/ Heart Attack

ACTIVE COMPARATOR

Image patients who have had a heart attack

Drug: 64Cu-DOTA-ECL1i

Sarcoidosis

ACTIVE COMPARATOR

Image patients who have Sarcoidosis

Drug: 64Cu-DOTA-ECL1i

Myocarditis

ACTIVE COMPARATOR

Image patients with Myocarditis

Drug: 64Cu-DOTA-ECL1i

Cardiomyopathy

ACTIVE COMPARATOR

Image patients with cardiomyopathy

Drug: 64Cu-DOTA-ECL1i

Infected Cardiovascular Implantable Electronic Devices

ACTIVE COMPARATOR

Image patients with cardiovascular implanted medical devices

Drug: 64Cu-DOTA-ECL1i

Healthy Volunteers

ACTIVE COMPARATOR

Image healthy volunteers

Drug: 64Cu-DOTA-ECL1i

Interventions

64Cu-DOTA-ECL1i DRUG

Inject PET Radioisotope for imaging

Also known as: Imaging drug

Cardiomyopathy; Healthy Volunteers; Infected Cardiovascular Implantable Electronic Devices; Myocarditis; Post ST Elevation Myocardial Infarction/ Heart Attack; Sarcoidosis

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Kitty D Harrison, BSN, RN

CONTACT

314-747-0183; kittydharrison@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 4, 2021
• Study Start: November 24, 2018
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

US (1)