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OpenTrials
Completed

NCT Number: NCT05536960

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

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

Completed

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Key information

Conditions

Atheroscleroses, Coronary Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-Dotatate PET/CT

Other

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

Primary outcomes

  1. Difference in TBRmax

    Time frame: 1 day

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

Secondary outcomes

  1. Correlation between TBRmax and FAI.

    Time frame: 1 day

    Correlation of TBRmax with fat attenuation index, a specific CCTA parameter of vascular inflammation.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: DOLPHIN

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2022
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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