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Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction

Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05536960
Acronym
DOLPHIN
Enrollment
41
Registered
2022-09-13
Start date
2022-09-09
Completion date
2023-10-06
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atheroscleroses, Coronary

Brief summary

To assess whether vulnerable coronary plaques have more uptake of 68Ga-Dotatate than non-vulnerable plaques.

Interventions

One 68Ga-Dotatate PET/CT to determine uptake of tracer in the arterial wall.

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Difference in TBRmax1 dayDifference of target to background ratio (TBR)max in the coronary arteries between groups.

Secondary

MeasureTime frameDescription
Correlation between TBRmax and FAI.1 dayCorrelation of TBRmax with fat attenuation index, a specific CCTA parameter of vascular inflammation.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026