Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis

Not Applicable

Completed

• Conditions: Sarcoidosis
• Interventions: Radiation: Rubidium PET

• Registration Number: NCT01648933
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2012-04-12
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-20
• Study First Posted: 2012-07-25
• Primary Completion: 2015-09
• Study Completion: 2017-02
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sarcoidosis	Rubidium PET	Rubidium PET: Myocardial Perfusion Imaging

Primary Outcome Measures

Name	Time	Method
percentage of patient who has two different diagnostic and therapeutic attitude before knowing Rubidium-82 PET result and after knowing Rubidium-82 PET result	60 days	to assess diagnostic and therapeutic impacts of myocardial perfusion analysis with Rubidium-82 PET in cardiac sarcoidosis.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard; 🇫🇷 Paris, Ile De France, France