ACR/EULAR Endorsed Study to Develop New Diagnostic and Classification Criteria for Primary Systemic Vasculitis

Status: Unknown status
Location: See all (120) locations...
Study Type: Observational
SUMMARY

Vasculitis is group of diseases where inflammation of blood vessels is the common feature. Patients typically present with fever, fatigue, weakness and muscle and joint aches. These symptoms are very common among many different diseases, not just vasculitis. A clustering of other symptoms, physical examination findings, blood tests, radiology and biopsy help make the diagnosis. There are currently no criteria to help doctors make a diagnosis of vasculitis when a patient presents with these non specific symptoms and they are reliant on previous experience and disease definitions. One of the aims of this project is to develop diagnostic criteria for the primary systemic vasculitides (granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis, Churg Strauss syndrome, polyarteritis nodosa, giant cell arteritis, Takayasu arteritis). We, the investigators, will do this by studying a large group of patients with vasculitis and comparing them to a large group of patients that present in a similar way, but do not have vasculitis. By comparing the 2 groups we will create a list of items to differentiate between vasculitis and 'vasculitis mimics'. We also aim to update the current classification criteria. Classification criteria are used to group patients into different types of vasculitis, once a diagnosis of vasculitis has been made, and are useful for studying patients in clinical trials with similar or identical diseases. The current classification criteria (American college of Rheumatology 1990 criteria) were developed 20 years ago, before the availability of some important diagnostic tests (e.g. antineutrophil cytoplasmic antibodies [ANCA]), and are now not consistent with some of the current disease definitions. Therefore to progress future research in vasculitis, it is important that the classification criteria are updated. We will recruit 260 patients with each of the 6 types of vasculitis and compare them with 1300 controls (patients with the 5 other types of vasculitis), in order to determine the optimal combination of symptoms, signs and investigations that classify each person into the appropriate group.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Adult patients aged >18 years. There is no upper age limit.

• Ability to give informed consent. If the patient is unable to give informed consent as a result of death or physical incapacity, then informed assent from next of kin.

• Presumed diagnosis of a primary systemic vasculitis.

• Adult patients aged >18 years. There is no upper age limit.

• Ability to give informed consent. If the patient is unable to give informed consent as a result of death or physical incapacity, then informed assent from next of kin.

• Suspected diagnosis of a primary systemic vasculitis

• Adult patients aged >18 years. There is no upper age limit.

• Ability to give informed consent. If the patient is unable to give informed consent as a result of death or physical incapacity, then informed assent from next of kin.

• Patients presenting to secondary care with one of the following clinical presentations: I.Multi-system disease. Presentation of disease with at least 2 organs involved. II.Pulmonary-renal syndrome. Defined as haemoptysis / pulmonary haemorrhage with acute renal impairment. III.Acute renal failure IV.Acute respiratory distress. V.Chronic upper airways symptoms and signs. VI.Inflammatory polyarthritis. VII.Fever of unknown origin. VIII.Acute or chronic abdominal pain IX.Hypertension. X.Referred to secondary care with suspicion of vasculitis but confirmed not to have vasculitis. XII.New onset headache. XIII.Jaw or tongue pain. XIV.Sudden visual loss. XV.Limb claudication. XVI.Aortic aneurysm >5cm.

Locations
United States
Alabama
University of Alabama at Birmingham
Recruiting
Birmingham
California
Cedars-Sinai Medical Center, LA
Recruiting
Los Angeles
University of California, San Francisco
Recruiting
San Francisco
Massachusetts
Vasculitis Center, Boston University School of Medicine
Recruiting
Boston
Maryland
University of Maryland
Recruiting
Baltimore
Michigan
University of Michigan, Internal Medicine
Recruiting
Ann Arbor
Minnesota
Mayo Clinic
Recruiting
Rochester
North Carolina
University of North Carolina
Not yet recruiting
Chapel Hill
New Hampshire
Dartmouth-Hitchcock Medical Centre, Lebanon, NH
Recruiting
Lebanon
New York
New York University Langone Medical Centre
Not yet recruiting
New York
Ohio
Cleveland Clinic
Recruiting
Cleveland
Pennsylvania
University of Pennsylvania
Recruiting
Philadelphia
University of Pittsburgh
Recruiting
Pittsburgh
Utah
University Medical Center
Not yet recruiting
Salt Lake City
Other Locations
Argentina
Ramos Mejia Hospital, University of Buenos Aires
Recruiting
Buenos Aires
Hospital Interzonal San Juan Bautista
Recruiting
San Fernando Del Valle De Catamarca
Australia
ANU Medical Centre
Recruiting
Canberra
Royal Brisbane and Women's Hospital
Recruiting
Herston
Austria
Medical University Innsbruck
Recruiting
Innsbruck
Belgium
University Hospitals Leuven
Recruiting
Leuven
Canada
University of Calgary
Not yet recruiting
Calgary
St Joseph's Healthcare
Recruiting
Hamilton
McGill University
Recruiting
Montreal
St Joseph's Healthcare London, Ontario
Recruiting
Ontario
University of Ottawa
Recruiting
Ottawa
Sherbrooke University Hospital Centre
Recruiting
Sherbrooke
Mount Sinai Hospital, Toronto
Recruiting
Toronto
University of Manitoba
Recruiting
Winnipeg
China
Peking Union Medical College Hospital, Beijing
Recruiting
Beijing
Czech Republic
General University Hospital
Recruiting
Prague
General University Hospital, Prague
Recruiting
Prague
Denmark
Rigshospitalet
Recruiting
Copenhagen
Egypt
Assiut University, Assiut University Hospitals
Recruiting
Assiut
Cairo University, Kasr El Ainy Hospital
Recruiting
Cairo
Finland
Helsinki University Central Hospital
Recruiting
Helsinki
France
Cochin Hospital, Université Paris-descartes
Not yet recruiting
Paris
Germany
Universitätsklinikum Jena
Recruiting
Jena
University of Schleswig-Holstein
Recruiting
Luebeck
Universitätsklinikum Münster
Recruiting
Münster
Kreiskliniken Esslingen
Recruiting
Plochingen
University Hospital Tübingen
Recruiting
Tübingen
Hungary
University of Debrecen Medical and Health Science Center
Recruiting
Debrecen
India
Postgraduate Institute of Medical Education and Research, Chandigarh
Recruiting
Chandigarh
Nizam's Institute of Medical Sciences, Hyderabad
Recruiting
Hyderabad
Chatrapathi Shahuji Maharaj Medical Center, Lucknow (IProcess)
Recruiting
Lucknow
Medanta, Delhi
Recruiting
New Delhi
Christian Medical College & Hospital, Vellore
Recruiting
Vellore
Ireland
Cork University Hospital
Recruiting
Cork
St. Vincent's University Hospital, Dublin
Recruiting
Dublin 4
Italy
University of Parma
Recruiting
Parma
Arcispedale Santa Maria Nuova
Recruiting
Reggio Emilia
Santa Maria Nuova Hospital, Reggio Emilia
Recruiting
Reggio Emilia
Japan
Chiba University
Recruiting
Chiba
Kagawa University Hospital
Recruiting
Kagawa
Kameda Medical Centre, Kamogawa
Recruiting
Kamogawa City
St. Marianna University Hospital
Recruiting
Kanagawa
Kanazawa University Hospital
Recruiting
Kanazawa
Saitama Medical University
Recruiting
Kawagoe
Kyorin University Hospital
Recruiting
Mitaka
Miyazaki University Hospital
Recruiting
Miyazaki City
Okayama University Hospital
Recruiting
Okayama
Kitano Hospital
Recruiting
Osaka
Juntendo University Koshigaya Hospital
Recruiting
Saitama
Jichi Medical University Hospital
Recruiting
Tochigi-ken
University Tokyo Hospital
Recruiting
Tokyo
Tsukuba University Hospital
Recruiting
Tsukuba
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Recruiting
Mexico City
Instituto Nacional de Enfermedades Respiratorias
Recruiting
Mexico City
Netherlands
VU University Medical Center
Not yet recruiting
Amsterdam
University Medical Center Groningen
Recruiting
Groningen
New Zealand
Auckland District Health Board
Recruiting
Auckland
Waitemata District Health Board, North Shore Hospital
Not yet recruiting
Auckland
University of Otago, Christchurch
Recruiting
Christchurch
Waikato District Health Board
Recruiting
Hamilton
Norway
Hospital of Southern Norway
Recruiting
Kristiansand
The University Hospital of Northern Norway, Tromsø
Recruiting
Tromsø
Poland
University of Jagiellonian
Recruiting
Kraków
Portugal
Hospital Garcia de Orta, Almada
Recruiting
Almada
Santa Maria Hospital, Lisbon
Recruiting
Lisbon
Hospital Santo Antonio, Porto
Recruiting
Porto
Republic of Korea
Seoul National University Hospital
Recruiting
Seoul
Russian Federation
First Moscow State Medical University
Recruiting
Moscow
Slovenia
University Medical Centre Ljubljana
Recruiting
Ljubljana
Spain
Clinic Barcelona Hospital Universitari
Recruiting
Barcelona
Sri Lanka
University of Colombo
Recruiting
Columbo 8
Sweden
Lund University
Recruiting
Lund
Karolinska Institute, Stockholm
Not yet recruiting
Stockholm
Linköping University
Recruiting
Stockholm
Umeå University
Not yet recruiting
Umeå
Uppsala University Hospital
Not yet recruiting
Uppsala
Switzerland
University Hospital Basel
Recruiting
Basel
Immunologie-Zentrum Zurich
Not yet recruiting
Zurich
Turkey
Hacettepe University
Recruiting
Ankara
Fatih University Medical Faculty
Recruiting
Istanbul
Haydarpasa Education and Research Hospital
Not yet recruiting
Istanbul
Istanbul University, Cerrahpasa Medical School
Recruiting
Istanbul
Istanbul University, Istanbul Medical School
Recruiting
Istanbul
Marmara University Medical School
Recruiting
Istanbul
United Kingdom
Aberdeen Royal Infirmary
Recruiting
Aberdeen
Basildon and Thurrock University Hospitals NHS Foundation Trust
Recruiting
Basildon
University of Birmingham
Recruiting
Birmingham
Addenbrooke's Hospital
Recruiting
Cambridge
North Cumbria University Hospitals, The Cumberland Infirmary
Recruiting
Carlisle
Epsom and St Helier University Hospitals NHS Trust
Recruiting
Carshalton
Dudley Group of Hospitals, NHS FT
Recruiting
Dudley
NHS Greater Glasgow & Clyde, Gartnavel Hospital
Recruiting
Glasgow
Ipswich Hospital NHS Trust
Recruiting
Ipswich
NHS Fife, Whyteman's Brae Hospital, Windygates
Recruiting
Kirkcaldy
Imperial College Healthcare NHS Trust, Hammersmith Hospital
Recruiting
London
University of Manchester, Manchester Royal Infirmary
Recruiting
Manchester
Norfolk and Norwich University Hospital
Recruiting
Norwich
Nottingham University Hospitals NHS Trust (QMC)
Recruiting
Nottingham
Nuffield Orthopaedic Centre
Recruiting
Oxford
Oxford University Hospitals NHS Trust (The Churchill Hospital)
Recruiting
Oxford
Royal Berkshire NHS Trust
Recruiting
Reading
Queen's Hospital
Recruiting
Romford
Heatherwood & Wexham Park Hospitals NHS Foundation Trust
Recruiting
Slough
Southampton University Hospitals NHS Trust
Withdrawn
Southampton
Southend University Hospital NHS Trust
Recruiting
Westcliff-on-sea
York Hospital NHS Foundation Trust
Recruiting
York
Contact Information
Primary
Raashid A Luqmani
raashid.luqmani@ndorms.ox.ac.uk
+44 1865 738106
Backup
Anthea Craven
anthea.craven@ndorms.ox.ac.uk
Time Frame
Start Date: January 2011
Completion Date: December 2018
Participants
Target number of participants: 3588
Treatments
WG classification
Patients with Wegener's granulomatosis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
MPA classification
Patients with microscopic polyangiitis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
CSS classification
Patients with Churg Strauss syndrome. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
PAN classification
Patients with polyarteritis nodosa. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
Control Classification
For each of the diseases being evaluated (WG, MPA, CSS, PAN, GCA, TAK), patients with the other 5 diseases will be the control group. Within these groups, 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
WG diagnostic
Patients with a new presentation of Wegener's granulomatosis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
MPA diagnostic
Patients with a new presentation of microscopic polyangiitis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
CSS diagnostic
Patients with a new presentation of Churg Strauss syndrome. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
PAN diagnostic
Patients with a new presentation of polyarteritis nodosa. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
Control diagnostic
Patients without vasculitis, but presenting with similar features to the 6 different types of vasculitis being studied. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
GCA classification
Patients with giant cell arteritis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
TAK classification
Patients with Takayasu arteritis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Classification criteria.
GCA diagnostic
Patients with a new diagnosis of giant cell arteritis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
TAK diagnostic
Patients with a new diagnosis of Takayasu arteritis. 1st half of these patients will be assigned to the development cohort and the second half to the validation cohort. Diagnostic criteria.
Authors
Vladamir Tesar, Kim Liang, Vicky Quincey, Andrea Hinojosa, Seval Pehlivan, Siddhart Das, Rainer Kloche, Amira Shahin, Daniel A Albert, Ronald Falk, Lisa Stamp, Leonard Calabrese, Sanjeev Patel, Thomas Neumann, Eamonn Molloy, Peter Grayson, Eric Matteson, Yusuf Yazici, Michael Weisman, Kazuo Suzuki, Curry Koening, Jamal Mikdashi, Peter A Merkel, Professor William J McCune, Johan Bratt, Emilio Besada, Paul Gatenby, Bernhard Hellmich, Bhaskar Dasgupta, Jan Sznajd, Oliver Flossmann, Loic Guillevin, Raashid Luqmani, Joanna Robson, Matthew Adler, John Mclaren, Cord Sunderkötter, Peter Lanyon, Alaa Hassan, Nagui Gendi, Chetan Mukhtyar, Julia Holle, Kuntal Chakravarty, Niels Rasmussen, Sergey Moiseev, Aman Sharma, Caroline Savage, Navjot Dhindsa, Michael Clarkson, Luis Felipe Flores-Suárez, Rajiva Gupta, Kazuo Matsui, Michael Walsh, Inoshi Atukorala, Lillian Barra, Shigeto Kobayashi, Wako Yumura, Eri Muso, Nataliya Milman, Simon Carette, Thomas Daikeler, Eduardo Kerzberg, Liza Rajasekhar, Miguel Rodrigues, Alojzija Hočevar, Christian Pineau, Ewa Berglin, Angelo Gaffo, Sergio Toloza, Maarten Boers, Mårten Segelmark, Hasan Yazici, Yoshihiro Arimura, Joerg Henes, Thomas Hauser, Daniel Blockmans, Koichi Amano, David Jayne, Nader Khalidi, Janak de Zoysa, Kunihiro Yamagata, Shouichi Fujimoto, Takashi Wada, Ann Knight, Sharon Chung, Haner Direskeneli, Dwarakanathan Ranganathan, Xinping Tian, Carlo Salvarani, Hirofumi Makino, Jukka Putaala, Augusto Vaglio, Pavel Novikov, Debashish Danda, Ian Bruce, Ravi Suppiah, Maria Cid, Abraham Rutgers, Ernestina Santos, Zoltan Szekanecz, Andreas Kronbichler, Richard Watts, Vladimir Tesar, Charles Jennette, Yeong-Wook Song, Nevin Hammam, Junichi Hirahashi, Omer Karadag, Sevil Kamali, Justin Mason, Rachel Hoyles, Bo Baslund, Colin Jones, Iain McInnes, Ruth Geraldes, Patrick Liang, Hiroaki Dobashi, Hidehiro Yamada, Andreas Diamantopoulos, Neil Basu, Gulen Hatemi
Sponsors
Collaborators: The Vasculitis foundation, The European League Against Rheumatism (EULAR), American College of Rheumatology
Leads: University of Oxford

This content was sourced from clinicaltrials.gov

Similar Clinical Trials