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

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

Status: Completed

Conditions: Atheroscleroses, Coronary

Treatments: Other: 68Ga-Dotatate PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT05536960

NL80263.018.21

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

68Ga-Dotatate PET/CT

Experimental group

Description:

These patients will undergo a 68Ga-Dotatate PET/CT scan.

Treatment:

Other: 68Ga-Dotatate PET/CT