Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis (PARCS)

This study is currently recruiting participants.
Verified August 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01648933
First received: April 12, 2012
Last updated: August 26, 2013
Last verified: August 2013

April 12, 2012
August 26, 2013
July 2012
February 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
to assess diagnostic and therapeutic impacts of myocardial perfusion analysis with Rubidium-82 PET in cardiac sarcoidosis.
Same as current
Complete list of historical versions of study NCT01648933 on ClinicalTrials.gov Archive Site
Analysis of the cost for the use of Sestamibi SPECT and Rb-PET as MPI agents in cardiac sarcoidosis. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis
Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis

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

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Sarcoidosis
Radiation: Rubidium PET
Myocardial Perfusion Imaging
Other Name: Rubidium PET
Experimental: Sarcoidosis

Rubidium PET:

Myocardial Perfusion Imaging

Intervention: Radiation: Rubidium PET
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Dominique Le Guludec, MD, PhD 01.40.25.84.10 ext + 33 dominique.leguludec@bch.aphp.fr
Contact: François Rouzet, MD, PhD 01 40 25 64 11 ext +33 francois.rouzet@bch.aphp.fr
France
 
NCT01648933
AOR10027
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Dominique Le Guludec, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP