Cardiac Sarcoidosis Multi-Center Prospective Cohort
A legfontosabb adatok
- Ki végzi
- Ottawa Heart Institute Research Corporation
- Hol
- Calgary, Edmonton, Halifax, Hamilton, London, Montreal, Newmarket, Ottawa, Regina, Toronto és Vancouver (Kanada)Mind a 13 helyszín megnézéseMég 1 másik országban, 1 helyszínen
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 1500 fő, tervezett
- Kezdés
- 2012. aug.
- Várható befejezés
- 2035. dec.
- A vizsgálat típusa
- Megfigyeléses
- A regiszteradat frissítve
- 2026. november 4.
Ki vehet részt
- Életkor
- 18 év – 99 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 12 feltétel megnézéseKevesebb
Ki vehet részt
- To diagnose Clinically Manifest CS all following criteria must be met:
- (i) Positive biopsy* for Sarcoid (either EMB or extra-cardiac) AND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis AND (iii) one or more of the following clinical features:
- advanced conduction system disease (sustained Mobitz II AV block or third degree AV block)
- non- sustained or sustained ventricular arrhythmia
- ventricular dysfunction (LVEF < 50% and/or RVEF < 40%) AND (iv) No alternative explanation for clinical features AND (v) FDG-PET suggestive of active CS; To diagnose clinically silent CS all of the following criteria must be met; (i) Biopsy proven extra-cardiac sarcoidosis; AND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis; AND (iii) CMR suggestive of cardiac sarcoidosis; AND (iv) Does not have criteria for clinically manifest CS ie. should not have any of following
- advanced conduction system disease (sustained Mobitz II AV block or third degree AV block)
- non- sustained or sustained ventricular arrhythmia
- ventricular dysfunction (LVEF < 50% and/or RVEF < 40%); Patients with negative CMR will be designated as 'extra-cardiac sarcoidosis with no evidence of CS' and followed as control
Ki nem vehet részt
- age < 18 years
- unable or unwilling to provide informed consent
- patients who are pregnant or lactating
- patients with known claustrophobia
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 99 év között vagy?
Helyszínek itt: Kanada
Még 1 másik országban, 1 helyszínen
- Libin Cardiovascular Institute of AlbertaCalgary, KanadaContact: Russell Quinn, MDRésztvevőt keres
- University of Alberta HospitalEdmonton, KanadaContact: Tomascz Hruczkowski, MDRésztvevőt keres
- QEII Health Sciences CenterHalifax, KanadaContact: Kim Anderson, MDRésztvevőt keres
- Hamilton Health Sciences CentreHamilton, KanadaContact: Jeff Healey, MDRésztvevőt keres
- London Health Sciences CentreLondon, KanadaContact: Lorne Gula, MDRésztvevőt keres
- Centre Hospitalier de l"Universite de Montreal-Hotel DieuMontreal, KanadaContact: Julie Fleury, RNToborzás még nem indult
- McGill University Health CentreMontreal, KanadaContact: Fiorella RaftiRésztvevőt keres
- Montreal Heart InstituteMontreal, KanadaContact: Lena Rivard, MDRésztvevőt keres
- Southlake Regional Health CentreNewmarket, KanadaContact: Bernice Tsang, MDRésztvevőt keres
- University of Ottawa Heart InstituteOttawa, KanadaContact: Janine E Ryan, BA HRésztvevőt keres
- Prairie Vascular Research Inc-Regina General HospitalRegina, KanadaContact: Kendra TownsendRésztvevőt keres
- Toronto General HospitalToronto, KanadaContact: Andrew Ha, MDRésztvevőt keres
- St. Paul's HospitalVancouver, KanadaContact: Shanta Chakrabarti, MDRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
Recent data has shown that sarcoidosis, presenting initially with cardiac manifestations (CS) of either conduction system disease or cardiomyopathy and sustained VT, is not uncommon. A Canadian physician survey found that most physicians do not investigate for CS as a possibility in these situations. Thus many patients with clinically important CS are going un-diagnosed. A study from Finland showed that missing the diagnosis of CS in these patients' leads to significant mortality and morbidity.
A teljes eredeti leírásKevesebb
There are no published clinical consensus guidelines on treatment of CS. Corticosteroid therapy is advocated by most experts. This is based on very modest data from small retrospective observational studies using variable definitions of clinical response. The effect of corticosteroid treatment on the clinical course of CS has not been studied in prospective studies and will be one of the aims of this project. Recent physician surveys regarding CS, in Canada and the US, found that current clinical practice varies widely. The 2008 American College of Cardiology/American Heart Association/Heart Rhythm society guidelines recommend implantation of a defibrillator (Class IIa recommendation) to prevent sudden cardiac death. The most recent Canadian device therapy guidelines do not mention CS.
A multi-center collaborative approach to study CS is greatly needed." The investigators propose exactly that i.e. a multi-center prospective cohort to start to answer clinical questions. The investigators have formed the CANADIAN CARDIAC SARCOIDOSIS RESEARCH GROUP. The group includes respirologists with an interest in sarcoidosis, cardiac electrophysiologists, cardiac imaging specialists with extensive experience in imaging of sarcoidosis and biostatisticians. The research will be in two phases; a registry of current diagnostic approaches, treatment and prognosis, and a randomized clinical trial of the effect of corticosteroid treatment on the clinical course of cardiac sarcoidosis.
A vizsgálat csoportja
- CS screened as underlying etiology
1. Patients with active Clinically Manifest CS 2. Patients diagnosed with extra-cardiac sarcoidosis and being screened for CS
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Cardiac Sarcoidosis Multi-Center Prospective Cohort Study
- Illeszkedési kérdések
- Forrás: NCT01477359: ki vehet részt
- A regiszteradat frissítve
- 2026. november 4.