Clinical Trial: Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients and the Mechanism

Brief Summary: The purpose is to test whether daily ischemic conditioning of the arms over 30 days could reduce the frequency and severity of angina pectoris and improve the life quality of refractory angina pectoris patients.

Detailed Summary: Refractory angina pectoris denotes "chronic stable angina that persists despite optimal medication and when revascularisation is unfeasible or where the risks are unjustified". These patients could potentially be relieved by non-conventional treatments like remote ischemic conditioning, and actually this effect has been observed in several cases in the center of the sponsor. This study is a pilot study to measure the efficacy and safety of this method in this group of patients.
Sponsor: Navy General Hospital, Beijing

Current Primary Outcome:

  • Frequencies of angina pectoris onset [ Time Frame: 30 days ]
    The total times of angina pectoris onset over one week
  • Canadian Cardiovascular Society Angina Class [ Time Frame: 30 days ]
    Ranging from class 1 to class 4 according to its definition


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Flow mediated vasodilation in percentage increase [ Time Frame: 30 days ]
    Reported as percent increase of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional.
  • Flow mediated vasodilation in absolute increase [ Time Frame: 30 days ]
    Reported as absolute increase (cm) of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional.
  • Self-Rating Anxiety Scale [ Time Frame: 30 days ]
    Reported as the Self-Rating Anxiety score
  • Self-Rating Depression Scale [ Time Frame: 30 days ]
    Reported as the Self-Rating Depression score
  • Inflammatory cytokines expression [ Time Frame: 30 days ]
    Reported as the serum levels of inflammatory cytokines measured by ELISA kits, including tumor necrosis factor(TNF-α)，Interleukine(IL)-6，and IL-10; The expression of signaling proteins in separated blood mononuclear cells,including hypoxia inducible factor(HIF) 1α.
  • Grip strength [ Time Frame: 30 days ]
    Measured by a simple Grip strength meter (CAMRY) and reported as kilograms of strength.
  • Skin and muscle abnormalities [ Time Frame: 1,7 and 30 days ]
    Whether or not the skin of the arm has bruises, and whether or not the arm has sore or pain feeling.
  • Circulating CD34+ progenitor cells [ Time Frame: 30 days ]
    The percent of circulating cluster of differentiation(CD)34+ progenitor cells in separated mononuclear cells measured by flow cytometry.


Original Secondary Outcome: Same as current

Information By: Navy General Hospital, Beijing

Dates:
Date Received: June 21, 2015
Date Started: January 2015
Date Completion: January 2017
Last Updated: July 15, 2015
Last Verified: July 2015