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Completed

NCT Number: NCT01648933

Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, Île-de-France Region, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rubidium PET

Radiation

Myocardial Perfusion Imaging

Primary outcomes

  1. 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

    to assess diagnostic and therapeutic impacts of myocardial perfusion analysis with Rubidium-82 PET in cardiac sarcoidosis.

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PARCS

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Jul 25, 2012
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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