Digital Ulceration
CAP
A Multicenter, Prospective Cohort Study Using Nailfold VideoCAPillaroscopy(NVC) and Other Factors to Determine the Risk of Developing Digital Ulceration in Patients With Systemic Sclerosis (SSc)
1 other identifier
observational
630
15 countries
50
Brief Summary
The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 17, 2011
CompletedFirst Posted
Study publicly available on registry
June 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJuly 15, 2013
July 1, 2013
1.5 years
June 17, 2011
July 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Occurence of first new digital ulcer (DU)
Occurrence of the first new digital ulcer (DU) within 6 months
6 months
Study Arms (2)
SSc DU-history subgroup
Systemic sclerosis patients with history of digital ulcers
SSc with No-DU-history subgroup
Systemic sclerosis patients with no history of digital ulcers
Eligibility Criteria
Patients with Systemic Sclerosis with or without a history of digital ulcers (DU)
You may qualify if:
- For all patients:
- Signed informed consent prior to enrollment
- Male or female, ≥ 18 years of age
- Diagnosis of systemic sclerosis (SSc) according to the American College of Rheumatology and/or limited cutaneous SSc or diffuse cutaneous SSc according to LeRoy criteria
- For patients with no history of digital ulcers (DU) and no DU at enrollment only:
- \- Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature
You may not qualify if:
- SSc sine scleroderma (without any skin involvement)
- Patients who underwent stem cell transplantation
- Participation in interventional clinical trials within 3 months prior to enrollment and/or during the study
- Inability to undergo Nailfold Videocapillaroscopy (NVC) assessment (e.g., inability to extend fingers sufficiently)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actelionlead
Study Sites (50)
Medizinische Universität Graz
Graz, 8036, Austria
Universitätsklinik für Innere Medizin Wien
Vienna, 1090, Austria
Sozialmedizinisches Zentrum Süd-Kaiser-Franz-Josef-Spital
Vienna, 1100, Austria
Hanusch Krankenhaus der Gebietskrankenkasse
Vienna, 1140, Austria
Université Libre de Bruxelles Hopital Erasme
Brussels, 1070, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Revmatologický ústav
Prague, 128 50, Czechia
Centre Hospitalier Universitaire Amiens
Amiens, 80054, France
Centre Hospitalier Universitaire de Grenoble
La Tronche, 38700, France
CHRU de Lille, hopital Claude Huriez, Service des maladies du sang
Lille, 59037, France
CHU Dupuytren
Limoges, 87042, France
Centre Hospitalier Universitaire de Nantes
Nantes, 44093, France
Groupe Hospitalier Cochin Saint Vincent de Paul
Paris, 75014, France
Hôpital Tenon
Paris, 75020, France
Asklepios Klinikum Bad Abbach
Bad Abbach, 93077, Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, 61321, Germany
Charité Universitätsmedizin Berlin
Berlin, 10117, Germany
Sankt Josef-Hospital, Klinikum der Ruhr-Universität Bochum
Bochum-Gerthe, 44805, Germany
Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln
Cologne, 50931, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Universitätsklinikum Halle (Saale)
Halle, 06112, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Laiko Hospital
Athens, 11527, Greece
Rambam Medical Center
Haifa, 31096, Israel
Bnai Zion Medical Center
Haifa, 33394, Israel
Meir Medical Center
Kfar Saba, 49281, Israel
Universita degli Studi di Brescia
Brescia, 25123, Italy
Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro
Catanzaro, 88100, Italy
Azienda Ospedale San Martino
Genova, 16132, Italy
Ospedale Santa Ciara
Pisa, 56126, Italy
Policlinico Umberto I
Roma, 00161, Italy
Complesso Integrato Columbus
Roma, 00168, Italy
Vrije Universiteit Medisch Centrum
Amsterdam, 1007 MB, Netherlands
Revmatismesykehuset
Lillehammer, 2609, Norway
Hospital Geral de Santo Antonio
Porto, 4099-001, Portugal
Hospital Sant Pau
Barcelona, 08025, Spain
Hospital Vall D'Hebron
Barcelona, 08035, Spain
Hospital de Mostoles
Madrid, 28935, Spain
Hospital Doctor Peset
Valencia, 46017, Spain
Centre Hospitalier Universitaire Vaudoise
Lausanne, 1011, Switzerland
Kantonspital Sankt Gallen
Sankt Gallen, 9007, Switzerland
UniversitätsSpital Zürich
Zurich, 8091, Switzerland
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34093, Turkey (Türkiye)
Bath Institute for Rheumatic Diseases
Bath, BA1 1RL, United Kingdom
Chapel Allerton Hospital
Leeds, LS7 4SA, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Hope Hospital
Salford, M6 8HD, United Kingdom
Wrightington Hospital
Wigan, WN6 9EP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2011
First Posted
June 21, 2011
Study Start
January 1, 2011
Primary Completion
July 1, 2012
Study Completion
August 1, 2012
Last Updated
July 15, 2013
Record last verified: 2013-07