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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
The subjects will receive twice daily of 4×5min/5min ischemic/reperfusion of both arms (remote ischemic conditioning) over 30 days using the "TDFT-12-A2" device produced by "Shenzhen TDF Tai Smart technology Co., Ltd."
The subjects will receive optimal medical treatment according up-to-date guidelines, including adequate antiplatelet therapy, statins, β-blocker and nitrates, plus angiotensin converting enzyme inhibitor(ACEI)/angiotensin receptor blocker(ARB),oral anticoagulants, if necessary.
Heart Center, Navy General Hospital of PLA
Beijing, Beijing Municipality, China
RECRUITINGFrequencies of angina pectoris onset
The total times of angina pectoris onset over one week
Time frame: 30 days
Canadian Cardiovascular Society Angina Class
Ranging from class 1 to class 4 according to its definition
Time frame: 30 days
Flow mediated vasodilation in percentage increase
Reported as percent increase of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional.
Time frame: 30 days
Flow mediated vasodilation in absolute increase
Reported as absolute increase (cm) of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional.
Time frame: 30 days
Self-Rating Anxiety Scale
Reported as the Self-Rating Anxiety score
Time frame: 30 days
Self-Rating Depression Scale
Reported as the Self-Rating Depression score
Time frame: 30 days
Inflammatory cytokines expression
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.
Time frame: 30 days
Grip strength
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Measured by a simple Grip strength meter (CAMRY) and reported as kilograms of strength.
Time frame: 30 days
Skin and muscle abnormalities
Whether or not the skin of the arm has bruises, and whether or not the arm has sore or pain feeling.
Time frame: 1,7 and 30 days
Circulating CD34+ progenitor cells
The percent of circulating cluster of differentiation(CD)34+ progenitor cells in separated mononuclear cells measured by flow cytometry.
Time frame: 30 days