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

Primary Purpose

Atheroscleroses, Coronary

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
68Ga-Dotatate PET/CT
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atheroscleroses, Coronary

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Academic Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-Dotatate PET/CT

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2022
Last Updated
October 14, 2022
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT05536960
Brief Title
Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction
Acronym
DOLPHIN
Official Title
Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
February 9, 2023 (Anticipated)
Study Completion Date
February 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atheroscleroses, Coronary

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-Dotatate PET/CT
Arm Type
Experimental
Arm Description
These patients will undergo a 68Ga-Dotatate PET/CT scan.
Intervention Type
Other
Intervention Name(s)
68Ga-Dotatate PET/CT
Intervention Description
One 68Ga-Dotatate PET/CT to determine uptake of tracer in the arterial wall.
Primary Outcome Measure Information:
Title
Difference in TBRmax
Description
Difference of target to background ratio (TBR)max in the coronary arteries between groups.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Correlation between TBRmax and FAI.
Description
Correlation of TBRmax with fat attenuation index, a specific CCTA parameter of vascular inflammation.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reindert Oostveen, M.D.
Phone
205667050
Ext
+31
Email
r.oostveen@amsterdamumc.nl
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik S Stroes, MD PhD
Phone
+31205665978
Email
e.s.stroes@amc.uva.nl
First Name & Middle Initial & Last Name & Degree
Erik S Stroes, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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