Trials / Unknown
UnknownNCT02341066
Endothelial Dysfunction Evaluation for Coronary Heart Disease Risk Estimation in Rheumatoid Arthritis (EDRA Study)
Evaluation of a New Score Incorporating Endothelial Dysfunction for the Assessment of Coronary Heart Disease Risk in Patients With Rheumatoid Arthritis: a 3-year Prospective Study.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,000 (estimated)
- Sponsor
- Azienda Ospedaliero Universitaria di Sassari · Academic / Other
- Sex
- All
- Age
- 45 Years – 84 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the contribution of the assessment of endothelial dysfunction (ED) in improving coronary hearth disease (CHD) risk stratification obtained by the Framingham risk score (FRS) in rheumatoid arthritis population (RA).
Detailed description
ED, determined by peripheral arterial tonometry (PAT), will be evaluated at baseline in 3000 RA patients free of previous cardiovascular events. Incident CHD events during the 3-year planned follow-up will be registered. A measure of the incremental yield of ED will be obtained comparing 2-year Framingham risk score for CHD (FRS) and FRS plus ED differential prognostic performances by C-statics and risk reclassification analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endothelial Dysfunction evaluation by EndoPAT | Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel). |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2019-03-01
- Completion
- 2019-03-01
- First posted
- 2015-01-19
- Last updated
- 2016-02-26
Locations
3 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT02341066. Inclusion in this directory is not an endorsement.