Dotatate to Locate Coronary Plaques at High-risk of Myoca... | NCT05536960

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

NCT05536960

Sponsor

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

Status

Completed

Last Update Posted

Feb 14, 2024Actual

Enrollment

41Actual

Phase

Not Applicable

Conditions

Atheroscleroses, Coronary

Interventions

68Ga-Dotatate PET/CT

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2022Actual

Primary Completion Date

Oct 6, 2023Actual

Completion Date

Oct 6, 2023Actual

First Submitted Date

Sep 8, 2022

First Submission Date that Met QC Criteria

Sep 8, 2022

First Posted Date

Sep 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2024

Last Update Posted Date

Feb 14, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

E.S.stroes, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Principal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
68Ga-Dotatate PET/CT	Experimental	These patients will undergo a 68Ga-Dotatate PET/CT scan.	Other: 68Ga-Dotatate PET/CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
68Ga-Dotatate PET/CT	Other	One 68Ga-Dotatate PET/CT to determine uptake of tracer in the arterial wall.	68Ga-Dotatate PET/CT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Academic Medical Center		Amsterdam		1105AZ	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided