Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis

NCT ID: NCT01648933

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2017-02-28

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.

Conditions

Sarcoidosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sarcoidosis

Rubidium PET:

Myocardial Perfusion Imaging

Group Type: EXPERIMENTAL

Rubidium PET

Intervention Type: RADIATION

Myocardial Perfusion Imaging

Interventions

Rubidium PET

Myocardial Perfusion Imaging

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique Le Guludec, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

AOR10027

Identifier Type: -

Identifier Source: org_study_id