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

NCT ID: NCT05536960

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-09

Study Completion Date

2023-10-06

Brief Summary

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

Detailed Description

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Conditions

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Atheroscleroses, Coronary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-Dotatate PET/CT

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

Group Type EXPERIMENTAL

68Ga-Dotatate PET/CT

Intervention Type OTHER

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

Interventions

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68Ga-Dotatate PET/CT

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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E.S.stroes

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Academic Medical Center

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL80263.018.21

Identifier Type: -

Identifier Source: org_study_id

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