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

February 13, 2024 updated by: E.S.stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
To assess whether vulnerable coronary plaques have more uptake of 68Ga-Dotatate than non-vulnerable plaques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Academic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in TBRmax
Time Frame: 1 day
Difference of target to background ratio (TBR)max in the coronary arteries between groups.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between TBRmax and FAI.
Time Frame: 1 day
Correlation of TBRmax with fat attenuation index, a specific CCTA parameter of vascular inflammation.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2022

Primary Completion (Actual)

October 6, 2023

Study Completion (Actual)

October 6, 2023

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL80263.018.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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