Heart DiseasesPhase 1NCT05107596
Evaluation of CCR2 in Patients Post Myocardial Infarction
A Phase 1 study testing 64Cu-DOTA-ECL1i in people with Heart Diseases, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- What is being tested?
- 64Cu-DOTA-ECL1i
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2018to 24 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Kitty Harrison, 314-747-0183, harrisonk@mir.wustl.edu
About this study
Official title: Preliminary Evaluation of 64Cu-DOTA-ECL1i in Patients Post-ST-Elevation Myocardial Infarction(STEMI)
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.
Read the 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.
- Conditions
- Heart Diseases
- Being tested
- 64Cu-DOTA-ECL1i
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-DOTA-ECL1iDrug
Also called Imaging drug
Inject PET Radioisotope for imaging
| Study group | Role | What they receive |
|---|---|---|
| Post ST Elevation Myocardial Infarction/ Heart Attack | Active comparator | Image patients who have had a heart attack Receives: Drug: 64Cu-DOTA-ECL1i |
| Sarcoidosis | Active comparator | Image patients who have Sarcoidosis Receives: Drug: 64Cu-DOTA-ECL1i |
| Myocarditis | Active comparator | Image patients with Myocarditis Receives: Drug: 64Cu-DOTA-ECL1i |
| Cardiomyopathy | Active comparator | Image patients with cardiomyopathy Receives: Drug: 64Cu-DOTA-ECL1i |
| Infected Cardiovascular Implantable Electronic Devices | Active comparator | Image patients with cardiovascular implanted medical devices Receives: Drug: 64Cu-DOTA-ECL1i |
| Healthy Volunteers | Active comparator | Image healthy volunteers Receives: Drug: 64Cu-DOTA-ECL1i |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 or 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start24 Nov 2018
- Primary completion24 Nov 2025 (estimated)
- Study completion24 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107596
- Sponsor's protocol ID
- 201807140
- Status last verified
- Nov 2022
- First submitted
- 7 Oct 2021
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of 64Cu-DOTA-ECL1i in Patients Post-ST-Elevation Myocardial Infarction(STEMI)
- ClinicalTrials.gov ID
- NCT05107596
- Acronym / sponsor ID
- 201807140
- Conditions
- Heart Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 24 Nov 2018 (actual)
- Primary completion
- 24 Nov 2025 (estimated)
- Study completion
- 24 Nov 2025 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Post ST Elevation Myocardial Infarction/ Heart Attack | Active comparator | Drug: 64Cu-DOTA-ECL1iImage patients who have had a heart attack |
| Sarcoidosis | Active comparator | Drug: 64Cu-DOTA-ECL1iImage patients who have Sarcoidosis |
| Myocarditis | Active comparator | Drug: 64Cu-DOTA-ECL1iImage patients with Myocarditis |
| Cardiomyopathy | Active comparator | Drug: 64Cu-DOTA-ECL1iImage patients with cardiomyopathy |
| Infected Cardiovascular Implantable Electronic Devices | Active comparator | Drug: 64Cu-DOTA-ECL1iImage patients with cardiovascular implanted medical devices |
| Healthy Volunteers | Active comparator | Drug: 64Cu-DOTA-ECL1iImage healthy volunteers |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 64Cu-DOTA-ECL1iAlso: Imaging drugInject PET Radioisotope for imaging | Drug | Cardiomyopathy, Healthy Volunteers, Infected Cardiovascular Implantable Electronic Devices, Myocarditis, Post ST Elevation Myocardial Infarction/ Heart Attack, Sarcoidosis |
Primary outcome
Number of participants who have heart disease as shown in the images
Time frame: 1 or 2 days
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 64Cu-DOTA-ECL1i in people with Heart Diseases, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kitty D Harrison, BSN, RN (314-747-0183, kittydharrison@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who have heart disease as shown in the images (time frame: 1 or 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.