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Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis (PARCS)

Primary Purpose

Sarcoidosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rubidium PET
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis focused on measuring sarcoidosis, heart, Rubidium, PET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • patient < 18 years old

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sarcoidosis

Arm Description

Rubidium PET: Myocardial Perfusion Imaging

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Analysis of the cost for the use of Sestamibi SPECT and Rb-PET as MPI agents in cardiac sarcoidosis.
to compare the cost between the two exams and the health-economic impact of Sestamibi SPECT and Rb-PET as MPI agents in cardiac sarcoidosis.

Full Information

First Posted
April 12, 2012
Last Updated
October 10, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01648933
Brief Title
Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis
Acronym
PARCS
Official Title
Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims at assessing diagnostic and therapeutic impact of Rubidium-82 PET in cardiac sarcoidosis.
Detailed Description
The presence of cardiac involvement is a serious complication of sarcoidosis. Early diagnosis is challenging since it relies on an array of clinical, biological and imaging abnormalities. Myocardial perfusion imaging with sestamibi is currently a major feature of the diagnosis, since it allows to evidence both microcirculatory impairments and scar. However, some technical limitations are inherent to SPECT, mainly poor spatial resolution and lack of attenuation correction, resulting in the absence of flow quantification. Rubidium-82 (Rb) PET proved to be more sensitive and specific than sestamibi SPECT in the diagnosis of coronary artery disease. Furthermore, it allows noninvasive measurement of coronary flow reserve. Finally, it exposes patients to lower radiation dose than SPECT. Therefore, Rb PET may help to better identify cardiac involvement of sarcoidosis, and hence to better select those patients who require high-dose steroids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis
Keywords
sarcoidosis, heart, Rubidium, PET

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sarcoidosis
Arm Type
Experimental
Arm Description
Rubidium PET: Myocardial Perfusion Imaging
Intervention Type
Radiation
Intervention Name(s)
Rubidium PET
Intervention Description
Myocardial Perfusion Imaging
Primary Outcome Measure Information:
Title
percentage of patient who has two different diagnostic and therapeutic attitude before knowing Rubidium-82 PET result and after knowing Rubidium-82 PET result
Description
to assess diagnostic and therapeutic impacts of myocardial perfusion analysis with Rubidium-82 PET in cardiac sarcoidosis.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Analysis of the cost for the use of Sestamibi SPECT and Rb-PET as MPI agents in cardiac sarcoidosis.
Description
to compare the cost between the two exams and the health-economic impact of Sestamibi SPECT and Rb-PET as MPI agents in cardiac sarcoidosis.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) histologically proven sarcoidosis; (2) suspicion of cardiac involvement on symptoms, and/or ECG and/or echocardiogram. Exclusion Criteria: patient < 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Le Guludec, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis

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