NCT01648933

Brief Summary

The study aims at assessing diagnostic and therapeutic impact of Rubidium-82 PET in cardiac sarcoidosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

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

April 12, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

3.2 years

First QC Date

April 12, 2012

Last Update Submit

October 10, 2018

Conditions

Sarcoidosis

Keywords

sarcoidosisheartRubidiumPET

Outcome Measures

Primary Outcomes (1)

  • percentage of patient who has two different diagnostic and therapeutic attitude before knowing Rubidium-82 PET result and after knowing Rubidium-82 PET result

    to assess diagnostic and therapeutic impacts of myocardial perfusion analysis with Rubidium-82 PET in cardiac sarcoidosis.

    60 days

Secondary Outcomes (1)

  • Analysis of the cost for the use of Sestamibi SPECT and Rb-PET as MPI agents in cardiac sarcoidosis.

    9 months

Study Arms (1)

Sarcoidosis

EXPERIMENTAL

Rubidium PET: Myocardial Perfusion Imaging

Radiation: Rubidium PET

Interventions

Rubidium PETRADIATION

Myocardial Perfusion Imaging

Sarcoidosis

Eligibility Criteria

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

You may qualify if:

  • (1) histologically proven sarcoidosis;
  • (2) suspicion of cardiac involvement on symptoms, and/or ECG and/or echocardiogram.

You may not qualify if:

  • patient \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard

Paris, Île-de-France Region, 75018, France

Location

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Dominique Le Guludec, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

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

April 12, 2012

First Posted

July 25, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2015

Study Completion

February 1, 2017

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

FR(1)