Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis (PARCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01648933
First received: April 12, 2012
Last updated: August 26, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648933

Contacts
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

Locations
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   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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 26, 2013
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 August 28, 2014