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Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis (PARCS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: April 12, 2012
Last updated: June 23, 2016
Last verified: June 2016
The study aims at assessing diagnostic and therapeutic impact of Rubidium-82 PET in cardiac sarcoidosis.

Condition Intervention
Radiation: Rubidium PET

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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 [ Time Frame: 60 days ]
    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. [ Time Frame: 9 months ]
    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.

Enrollment: 53
Study Start Date: July 2012
Estimated Study Completion Date: December 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sarcoidosis

Rubidium PET:

Myocardial Perfusion Imaging

Radiation: Rubidium PET
Myocardial Perfusion Imaging

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01648933

Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard
Paris, Ile de France, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Dominique Le Guludec, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01648933     History of Changes
Other Study ID Numbers: AOR10027
Study First Received: April 12, 2012
Last Updated: June 23, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Lymphatic Diseases processed this record on May 25, 2017