Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis (PARCS)
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Purpose
The study aims at assessing diagnostic and therapeutic impact of Rubidium-82 PET in cardiac sarcoidosis.
| Condition | Intervention |
|---|---|
|
Sarcoidosis |
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 |
- 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.
- 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sarcoidosis
Rubidium PET: Myocardial Perfusion Imaging |
Radiation: Rubidium PET
Myocardial Perfusion Imaging
Other Name: Rubidium PET
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| 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 | |
| Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard | Recruiting |
| Paris, Ile de France, France, 75018 | |
| 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 | |
| Principal Investigator: | Dominique Le Guludec, MD, PhD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01648933 History of Changes |
| Other Study ID Numbers: | AOR10027 |
| Study First Received: | April 12, 2012 |
| Last Updated: | August 4, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
sarcoidosis heart Rubidium PET |
Additional relevant MeSH terms:
|
Sarcoidosis Lymphoproliferative Disorders Lymphatic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013