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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPC arm | Experimental | 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. |
|
| Control arm | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote ischemic conditioning (TDFT-12-A2) | Device | 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." |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhao, MD,PhD | Contact | 86-10-66951416 | zhaoli463700@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tianchang Li, MD, PhD | Heart center, Navy General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center, Navy General Hospital of PLA | Recruiting | Beijing | Beijing Municipality | 100048 | China |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Optimal medical treatment | Drug | 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. |
|
|
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 |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010335 | Pathologic Processes |