Vascular Disease Clinical Trial
— SCLEROMICSOfficial title:
Metabolomic Analysis of Systemic Sclerosis
NCT number | NCT02298777 |
Other study ID # | 5723 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 2014 |
Est. completion date | February 2026 |
Currently investigators do not have diagnostic and prognostic markers for SSc which almost always starts with a vascular disease (Raynaud's disease) isolated for several years. The primary purpose is to highlight discriminating metabolic profiles depending on the characteristics of the disease, allowing early diagnosis of SSc at the onset of vascular lesions, by comparing the profiles of SSc beginners (<3 years) to established forms (> 3 years). Secondary purposes: - Prognosis: to study the metabolomics profile of SSc when a visceral complication occurs - Diagnosis: to compare the metabolomics profile of SSc to undifferentiated connective tissue disease (UCDT), Raynaud's disease (RD), vascular disease (VD) and healthy controls - Exploratory: to compare the metabolomics profile of blood, urine and skin of SSc patients
Status | Recruiting |
Enrollment | 140 |
Est. completion date | February 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - Group 1 (scleroderma) : Patients with ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001) - Group 2 (UCDT) : Patients with criteria proposed by Mosca et al. (1998) - Group 3 (Raynaud) : Patients with primary and isolated Raynaud disease - Group 4 (vascular disease) : Patients with type 2 diabetes, occlusive vascular disease, history of myocardial infarction or ischemic stroke - Group 5 (healthy control) : healthy subjects (no sign of connective tissue disease, no Raynaud, no vascular disease) Exclusion criteria: - Group 1 (scleroderma) : Patients not fulfilling ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001), or with another auto-immune disease - Group 2 (UCDT) : Patients not fulfilling criteria proposed by Mosca et al. (1998) - Group 3 (Raynaud) : Patients with no Raynaud disease - Group 4 (vascular disease) : Patients with no vascular disease - Group 5 (healthy control) : Patients with sign of connective tissue disease, Raynaud, or vascular disease) |
Country | Name | City | State |
---|---|---|---|
France | CHU | Dijon | |
France | Hôpitaux privés de Metz | Metz | |
France | CHU | Nancy | |
France | CHU | Reims | |
France | Hôpitaux Universitaires de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of metabolomics profiles between SSc beginners (<3 years) and SSc established forms (> 3 years) at baseline inclusion. | Metabolomic profiles will be classified in a database and compared. | 1 point at patient's inclusion visit | |
Secondary | Study and comparison of discriminating metabolomics profiles for prognosis, diagnosis and exploration of SSc. | Metabolomic profiles will be classified in a database and compared between each other's (SSc, UCDT, RD, VD and healthy control arms) We will look for a correlation between these profiles and the evolution of clinical and biological characteristics of SSc (SSc arm) | 1st point at patient's inclusion visit (all arms) + 2nd point at patient's complication (group1) during 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01205776 -
EXCEL Clinical Trial
|
N/A | |
Completed |
NCT02542267 -
In-Stent Restenosis Post-Approval Study
|
N/A | |
Completed |
NCT01608035 -
Sciatic Perineural Versus Stump Catheter for Below Knee Amputation
|
Phase 0 | |
Completed |
NCT00987181 -
Non-Contact Measurement of Aortic Compliance
|
N/A | |
Completed |
NCT00865124 -
Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease
|
N/A | |
Completed |
NCT01182428 -
XIENCE V: SPIRIT WOMEN Sub-study
|
Phase 4 | |
Completed |
NCT00759681 -
ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial
|
Phase 3 | |
Completed |
NCT00633659 -
Pilot Study of Hemospan® in Patients With Chronic Critical Limb Ischemia
|
Phase 2 | |
Completed |
NCT00341562 -
Genomics of In-Stent Restenosis
|
N/A | |
Completed |
NCT00110604 -
The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing
|
N/A | |
Completed |
NCT01355406 -
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
|
N/A | |
Not yet recruiting |
NCT02843854 -
Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms
|
Phase 1 | |
Completed |
NCT01205789 -
EXCEL Clinical Trial (Universal Registry)
|
N/A | |
Completed |
NCT01221610 -
BIOLUX P-I First in Man Study
|
N/A | |
Completed |
NCT01229358 -
Clinical Trial of a Silver Eluting Dressing System
|
Phase 4 | |
Recruiting |
NCT01358630 -
Vascular and Periodontal Disease - Microbial, Genetic and Histological Causalities
|
N/A | |
Completed |
NCT00782015 -
Effects of Almonds on Vascular Reactivity in Patients With Coronary Artery Disease
|
N/A | |
Completed |
NCT00805831 -
Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
|
N/A | |
Withdrawn |
NCT00334724 -
Home Blood Pressure-guided Antihypertensive Intervention for Elderly (HBP-GUIDE) Study
|
Phase 4 | |
Active, not recruiting |
NCT02751099 -
Bone and Cardiovascular Disease After Kidney Transplant
|