NCT05536960

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

September 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2023

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

September 8, 2022

Last Update Submit

February 13, 2024

Conditions

Atheroscleroses, Coronary

Outcome Measures

Primary Outcomes (1)

  • Difference in TBRmax

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

    1 day

Secondary Outcomes (1)

  • Correlation between TBRmax and FAI.

    1 day

Study Arms (1)

68Ga-Dotatate PET/CT

EXPERIMENTAL

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

Other: 68Ga-Dotatate PET/CT

Interventions

68Ga-Dotatate PET/CTOTHER

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

68Ga-Dotatate PET/CT

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 13, 2022

Study Start

September 9, 2022

Primary Completion

October 6, 2023

Study Completion

October 6, 2023

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)