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

Not Applicable

Completed

• Conditions: Atheroscleroses, Coronary
• Interventions: Other: 68Ga-Dotatate PET/CT

• Registration Number: NCT05536960
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-08
• Study Start: 2022-09-09
• Study First Posted: 2022-09-13
• Primary Completion: 2023-10-06
• Study Completion: 2023-10-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Difference in TBRmax	1 day	Difference of target to background ratio (TBR)max in the coronary arteries between groups.

Secondary Outcome Measures

Name	Time	Method
Correlation between TBRmax and FAI.	1 day	Correlation of TBRmax with fat attenuation index, a specific CCTA parameter of vascular inflammation.

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands