Clinical Trial: A Trial of Ischemic Preconditioning in Raynaud's Phenomenon (RP)

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Randomized, Single-blinded Placebo-controlled Trial of Ischemic Preconditioning in Raynaud's Phenomenon (RP)

Brief Summary: This trial will test the efficacy of brief periods of controlled limb ischemia (remote ischemic preconditioning, RIPC) as an effective treatment of patients with Raynaud's Phenomenon (RP).The hypothesis of this trial is that due to its vasoprotective effects, RIPC would be more effective than placebo in the treatment of both primary and secondary RP, as defined by decreased frequency, duration, and severity of attacks. This trial was also designed to monitor the tolerance of RIPC in a rheumatologic population. Patients will not be required to stop any current treatment for RP.

Detailed Summary:

Raynaud's phenomenon (RP) is defined as vasospasms of arteries causing pallor and at least one other color change upon reperfusion such as cyanosis or redness. The current treatments for RP (channel blockers, PDE5 inhibitors, etc.) have only modest efficacy and are associated with many side-effects including headaches, flushing, hypotension and fluid retention that require stopping the medication. Thus, identification of an innovative treatment is an important therapeutic goal in RP patients.

Ischemic preconditioning is a simple non-invasive procedure which consists of 4 consecutive episodes of brief ischemia caused by placing a pneumatic cuff at the level of the brachial artery and inflating it to 200 mm Hg for 2.5 minutes, followed by 2.5 minutes of reperfusion. Over 20 years IPC has generated tremendous scientific interest being described as the most powerful available form of in vivo protection against ischemic injury.

This clinical trial will measure the efficiency of RIPC in decreasing the frequency, duration and severity of RP attacks. 24 patients will be recruited from the Rheumatology clinic of St. Joseph's Health Care in London, Ontario. As they enter the trial, subjects will be assigned to a treatment or a placebo group according to a pre-set randomization schedule. The trial will be single-blinded (patient).

The primary outcome measures (frequency, duration and severity) will be assessed by the patient on a daily basis using a journal provided by the investigator. Secondary outcome measures will include functions questionnaires (Raynaud's Condition Score, s-HAQ-DI, DASH) and biological markers of endothelial damage (P-selectin, I-CAM, VEGF), will be conducted every two weeks: at baseline, post-placebo, post-washout, and post-treatment phases.

  • Changes in frequency of RP attacks [ Time Frame: Entire study duration (8 weeks including pretreatment and washout period) ]
    The subject will self-assess the number of RP attacks daily in their RP diary.
  • Changes in severity of RP attacks [ Time Frame: Entire study duration (8 weeks including pretreatment and washout period) ]
    Severity will be evaluated on a scale of 1 to 10. The subject will self-assess the severity in their RP diary. (0 = no difficulty with RP condition, 10 = extreme difficulty with RP condition).
  • Changes in duration of RP attacks [ Time Frame: Entire study duration (8 weeks including pretreatment and washout period) ]
    The subject will self-assess the duration (in minutes) of RP attacks daily in their RP diary.


    • Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Functions questionnaires (Raynaud's Condition Score) [ Time Frame: Every 2 weeks at clinic visits (baseline, after intervention, after washout, and after placebo) for a total of 6 weeks ]
    • Biological marker of endothelial damage (P-selectin) [ Time Frame: Every 2 weeks at clinic visits (baseline, after intervention, after washout, and after placebo) for a total of 6 weeks ]
    • Biological marker of endothelial damage (I-CAM) [ Time Frame: Every 2 weeks at clinic visits (baseline, after intervention, after washout, and after placebo) for a total of 6 weeks ]
    • Biological marker of endothelial damage (VEGF) [ Time Frame: Every 2 weeks at clinic visits (baseline, after intervention, after washout, and after placebo) for a total of 6 weeks ]
    • Functions questionnaires (HAQ-DI) [ Time Frame: Every 2 weeks at clinic visits (baseline, after intervention, after washout, and after placebo) for a total of 6 weeks ]
      Health Assessment Questionnaire - Disability Index
    • Functions questionnaires (DASH) [ Time Frame: Every 2 weeks at clinic visits (baseline, after intervention, after washout, and after placebo) for a total of 6 weeks ]
      Disabilities of the Arm, Shoulder, and Hand


    Original Secondary Outcome: Same as current

    Information By: Lawson Health Research Institute

    Dates:
    Date Received: July 8, 2015
    Date Started: July 2015
    Date Completion: August 2016
    Last Updated: August 25, 2015
    Last Verified: August 2015