Atheroscleroses, CoronaryDOLPHINNCT05536960
Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction
A study testing 68Ga-Dotatate PET/CT in people with Atheroscleroses, Coronary, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
To assess whether vulnerable coronary plaques have more uptake of 68Ga-Dotatate than non-vulnerable plaques. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atheroscleroses, Coronary
- What is being tested?
- 68Ga-Dotatate PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Sep 2022to 6 Oct 2023
- Phase
- Interventional
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50 years and older
- Underwent CCTA imaging within 78 weeks from the screening visit
- Either CAD-RADS 4 or higher or 0/1 on CCTA.
- Able to provide written informed consent
Who cannot join
- History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of < 45 ml/min/1,73m2.
- CVD events/revascularization in history
- Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
- Chronic or recent (< 1 month) infections and/or clinical signs of acute infection.
- History of auto-immune diseases.
- Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices.
- Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
- Elevated liver enzymes (> 2 ULN of liver transaminases), acute liver failure or known liver disease.
Trial locations and contacts
1 site in 1 country.
About this study
To assess whether vulnerable coronary plaques have more uptake of 68Ga-Dotatate than non-vulnerable plaques.
- Conditions
- Atheroscleroses, Coronary
- Being tested
- 68Ga-Dotatate PET/CT
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-Dotatate PET/CTOther
One 68Ga-Dotatate PET/CT to determine uptake of tracer in the arterial wall.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-Dotatate PET/CT | Experimental | These patients will undergo a 68Ga-Dotatate PET/CT scan. Receives: Other: 68Ga-Dotatate PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in TBRmax
Difference of target to background ratio (TBR)max in the coronary arteries between groups.
Measured: 1 day
Secondary outcomes (1)
Correlation between TBRmax and FAI.
Correlation of TBRmax with fat attenuation index, a specific CCTA parameter of vascular inflammation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start9 Sep 2022
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atheroscleroses, CoronaryStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.S.stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536960
- Sponsor's protocol ID
- NL80263.018.21
- Acronym
- DOLPHIN
- Status last verified
- Feb 2024
- First submitted
- 8 Sep 2022
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05536960
- Acronym / sponsor ID
- DOLPHIN / NL80263.018.21
- Conditions
- Atheroscleroses, Coronary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 13 Sep 2022 (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 assess whether vulnerable coronary plaques have more uptake of 68Ga-Dotatate than non-vulnerable plaques.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-Dotatate PET/CT | Experimental | Other: 68Ga-Dotatate PET/CTThese patients will undergo a 68Ga-Dotatate PET/CT scan. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 50 years and older
- Underwent CCTA imaging within 78 weeks from the screening visit
- Either CAD-RADS 4 or higher or 0/1 on CCTA.
- Able to provide written informed consent
Key exclusion criteria (8 listed)
- History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of < 45 ml/min/1,73m2.
- CVD events/revascularization in history
- Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
- Chronic or recent (< 1 month) infections and/or clinical signs of acute infection.
- History of auto-immune diseases.
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 |
|---|---|---|
| 68Ga-Dotatate PET/CTOne 68Ga-Dotatate PET/CT to determine uptake of tracer in the arterial wall. | Other | 68Ga-Dotatate PET/CT |
Primary outcome
Difference in TBRmax
Time frame: 1 day
Difference of target to background ratio (TBR)max in the coronary arteries between groups.
1 secondary outcome
Correlation between TBRmax and FAI.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Atheroscleroses, Coronary
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-Dotatate PET/CT in people with Atheroscleroses, Coronary, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 14 Feb 2024. 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 Netherlands. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in TBRmax (time frame: 1 day). 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 14 Feb 2024.