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

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05536960
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atheroscleroses, Coronary	Other: 68Ga-Dotatate PET/CT	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction
• Anticipated Study Start Date: Sep 9, 2022
• Anticipated Primary Completion Date: Feb 9, 2023
• Anticipated Study Completion Date: Feb 9, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 68Ga-Dotatate PET/CT These patients will undergo a 68Ga-Dotatate PET/CT scan.	Other: 68Ga-Dotatate PET/CT; One 68Ga-Dotatate PET/CT to determine uptake of tracer in the arterial wall.

Outcome Measures

Primary Outcome Measures

1. Difference in TBRmax [1 day]

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

Secondary Outcome Measures

1. Correlation between TBRmax and FAI. [1 day]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Academic Medical Center	Amsterdam		Netherlands	1105AZ

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: E.S.stroes, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• ClinicalTrials.gov Identifier: NCT05536960
• Other Study ID Numbers: NL80263.018.21
• First Posted: Sep 13, 2022
• Last Update Posted: Sep 13, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myocardial Infarction; Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Infarction

Study Results

No Results Posted as of Sep 13, 2022