Evaluating a new imaging drug for heart attack patients
Preliminary Evaluation of 64Cu-DOTA-ECL1i in Patients Post-ST-Elevation Myocardial Infarction(STEMI)
This study is testing a new imaging drug to see if it can help find specific immune cells in the hearts of people who have had a heart attack or have heart inflammation.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT05107596 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of using 64Cu-DOTA-ECL1i, an investigational PET imaging drug, to detect specific immune cells in the heart tissue of individuals who have experienced a heart attack or have inflammatory heart disease. The study will utilize advanced imaging techniques, including PET/MR and PET/CT, to visualize CCR2+ monocytes and macrophages, which play a crucial role in tissue protection. By understanding the cellular response in the myocardium, researchers hope to gain insights into heart disease mechanisms and potential treatments.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 21 to 80 who have suffered a STEMI within the past 6 months or have other forms of inflammatory heart disease.
Not a fit: Patients with a history of significant cardiac, pulmonary, hepatic, or renal disease, or those with claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for heart disease and better understanding of post-heart attack recovery.
How similar studies have performed: While this approach is innovative, similar studies using PET imaging for heart disease have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Kitty D Harrison, BSN, RN
- Email: kittydharrison@wustl.edu
- Phone: 314-747-0183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.