NCT02062008

Brief Summary

The purpose of this study is to understand how simultaneous PET/MR acquisition can provide novel qualitative and quantitative biomarkers to guide clinical intervention and predict prognosis of patients with cardiovascular disease.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

February 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
2.8 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2018

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

June 16, 2021

Completed
Last Updated

June 16, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

February 7, 2014

Results QC Date

May 20, 2021

Last Update Submit

May 20, 2021

Conditions

Cardiac Disease

Keywords

Positron Emission Tomography-Magnetic Resonance ImagingCardiac Disease

Outcome Measures

Primary Outcomes (1)

  • Number of Quality PET and PET/MR Images With Regional Myocardial Uptake of 18F-Fluorodeoxyglucose (FDG) in Participants Without Overt Diagnosis of Ischemic Coronary Artery Disease.

    Visual analysis of collected image pairs. Evaluated by experienced imaging providers as yes or no.

    2 hours

Study Arms (1)

Cardiac patients receiving PET/MR

OTHER

PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.

Device: PET-MRI

Interventions

PET-MRIDEVICE

PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.

Cardiac patients receiving PET/MR

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with ischemic and non-ischemic cardiac disease referred for cardiac PET for viability imaging.

You may not qualify if:

  • Contraindications for MRI, including cardiac pacemaker, claustrophobia, retained metallic foreign body, cochlear implant, Aneurysm clip in the brain, pregnancy and eGFR less than 45%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF University of California in San Francisco

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Results Point of Contact

Title
miguel hernandez pampaloni
Organization
University of California San Francisco
miguel.pampaloni@ucsf.edu
4153531886

Study Officials

  • Karen G Ordovas, MD,MAS

    Assistent Professor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 13, 2014

Study Start

December 1, 2016

Primary Completion

February 10, 2018

Study Completion

February 10, 2018

Last Updated

June 16, 2021

Results First Posted

June 16, 2021

Record last verified: 2021-05

Locations

US(1)