Refractory Angina Pectoris
Conditions
Keywords
refractory angina pectoris, remote ischemic conditioning, life quality, anxiety, depression, inflammation
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 description
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.
Interventions
DEVICEremote ischemic conditioning (TDFT-12-A2)
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.
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequencies of angina pectoris onset | 30 days | The total times of angina pectoris onset over one week |
| Canadian Cardiovascular Society Angina Class | 30 days | Ranging from class 1 to class 4 according to its definition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Rating Anxiety Scale | 30 days | Reported as the Self-Rating Anxiety score |
| Self-Rating Depression Scale | 30 days | Reported as the Self-Rating Depression score |
| Inflammatory cytokines expression | 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. |
| Flow mediated vasodilation in percentage increase | 30 days | Reported as percent increase of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional. |
| Skin and muscle abnormalities | 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 | 30 days | The percent of circulating cluster of differentiation(CD)34+ progenitor cells in separated mononuclear cells measured by flow cytometry. |
| Grip strength | 30 days | Measured by a simple Grip strength meter (CAMRY) and reported as kilograms of strength. |
| Flow mediated vasodilation in absolute increase | 30 days | Reported as absolute increase (cm) of brachial artery diameter induced by release of the forearm after ligation, accessed by experienced ultrasound professional. |
Countries
China
Contacts
Primary ContactLi Zhao, MD,PhD
Outcome results
None listed