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Quantitative Assessment of the Synovial Vascularity in Early Inflammatory Arthritis

IRB Number: 25022

inactive

April 25, 2006

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

Co-Investigators

Summary

This cross-sectional pilot study will evaluate the ability of magnetic resonance angiography (MRA) and Power Doppler Ultrasound (PDU) to identify abnormal synovial vasculature in the hand and wrist of adults with less than six months of inflammatory arthritis symptoms.  MRA and PDU synovial vascularity scores will be correlated with clinical and serologic markers and with validated x-ray and magnetic resonance imaging (MRI) scores of disease severity.

The study will enroll 30 patients between August 2005 and October 2006 for a single, four hour study visit.

Inclusion/Exclusion Criteria

Inclusion Criteria

  1. Age 18-75
  2. Inflammatory arthritis for a least 6 weeks but no more than 6 months
  3. At least 3/7 criteria for rheumatoid arthritis by 1987 American College of Rheumatology revised criteria

Exclusion Criteria

  1. Diagnosis of another systemic rheumatic disease or crystalline arthritis (ie SLE, systemic sclerosis, psoriatic arthritis or psoriasis, gout, pseudogout, lyme arthritis, reactive arthritis, viral arthritis)
  2. Pregnant or nursing
  3. Unable to give informed consent
  4. Current use of glucocorticoids, methotrexate or other DMARD; patients on plaquenil will not be excluded
  5. Current treatment for cancer (except for non-melanomatous skin cancer)
  6. Active cellulitis or osteomyelitis
  7. Contraindication to MRI such as indwelling pacemaker
  8. Requirement of metal equipment (such as oxygen)
  9. Known claustrophobia
  10. Gadolinium allergy
  11. Raynauds phenomenon
  12. Lack of fluency in English. Unfortunately, we do not have the financial resources to offer full translation services for this small, internally funded, pilot trial

Contact Information

Lisa Vasanth, MD (Co-investigator)
212-774-7389

Lisa A. Mandl, MD, MPH (Principal Investigator)
212-774-2555