Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis

Sarcoidosis Clinical Trial

— PARCS  

Official title:

Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648933
• Other study ID #: AOR10027
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: February 2017

Study information

• Verified date: October 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Radiation:
• Rubidium PET
Myocardial Perfusion Imaging

Locations

Country	Name	City	State
France	Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	60 days
Secondary	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.	9 months