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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Refractory Angina Pectoris

Intervention / Treatment
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* Device: remote ischemic conditioning (TDFT-12-A2)
* Drug: Optimal medical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed angina pectoris that remains despite optimal medical treatment; No chance of further revascularization or refusal to do revascularization; The frequency and Canadian Cardiovascular Society (CCS) scale stays stable over the past 3 months before inclusion. Exclusion Criteria: Known or highly suspected abnormality of peripheral arteries, veins, or extremities; Infection or fever in the past month; Blood pressure over 180/110 millimeters of mercury (mmHg) or below 80/50mmHg; Refusal to comply with the study protocol; Currently under sulfonylureas or prostaglandins therapy; Other conditions that the researchers judge as inappropriate to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC arm<br>The subjects will be interviewed and have their baseline frequency and severity of angina pectoris recorded, then they will receive daily remote ischemic conditioning plus optimal medical treatment over 30 days. | Device: remote ischemic conditioning (TDFT-12-A2)<br>* 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.<br>* Other names: RIC;Drug: Optimal medical treatment<br>* 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.<br>* Other names: OMT;|
| Active Comparator: Control arm<br>The subjects will be interviewed and have their baseline frequency and severity of angina pectoris recorded, then they will receive optimal medical treatment over 30 days. | Drug: Optimal medical treatment<br>* 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.<br>* Other names: OMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequencies of angina pectoris onset | The total times of angina pectoris onset over one week | 30 days | 
| Canadian Cardiovascular Society Angina Class | Ranging from class 1 to class 4 according to its definition | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 30 days | 
| Self-Rating Anxiety Scale | Reported as the Self-Rating Anxiety score | 30 days | 
| Self-Rating Depression Scale | Reported as the Self-Rating Depression score | 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. | 30 days | 
| Grip strength | Measured by a simple Grip strength meter (CAMRY) and reported as kilograms of strength. | 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. | 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. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory angina pectoris, remote ischemic conditioning, life quality, anxiety, depression, inflammation