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

Atheroscleroses, Coronary Clinical Trial

— DOLPHIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05536960
• Other study ID #: NL80263.018.21
• Status: Completed
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: October 6, 2023

Study information

• Verified date: February 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atheroscleroses, Coronary
• Atherosclerosis
• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in TBRmax	Difference of target to background ratio (TBR)max in the coronary arteries between groups.	1 day
Secondary	Correlation between TBRmax and FAI.	Correlation of TBRmax with fat attenuation index, a specific CCTA parameter of vascular inflammation.	1 day