Protection of Arteritic Patients by Remote Preconditioning
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Walking distance during the calibrated treadmill test
研究概览
简要总结
Prospective, monocentric, randomised, double-blind study with 20 patients enrolled to be explored twice through a Cross-over strategy to determine whether remote preconditioning improves arteritic patients' ability to walk.
详细描述
Patients will be screened amongst arteritic patients who have undergone a positive treadmill test in Angers University Hospital, defined by a premature test stop caused by muscular pain associated to trans-cutaneous pressure of oxygen (TCPO2) drop.
After signing the informed consent, patients will take two treadmill tests in a week-span. According to randomization, patients will undergo the "remote preconditioning" procedure or the "control" procedure before the first treadmill test. The following week, in respect to a cross-over strategy patients will undergo the other procedure before the second treadmill test.
Only the study nurse will be advised of the procedure to do. Investigators will not be informed about the allocated procedure. Patients will not be informed about the procedure supposed to have a beneficial effect.
The treadmill test will be run according to a calibrated protocol. After a 2-minute stand-up resting period, the treadmill will progressively speed up to a 3.2km/h during one minute. This stage will be maintained with a 10% slope for 14 minutes. Then, the treadmill's slope and speed will increase progressively every minute according to a calibrated protocol. The test duration will be measured from the start of the walk to the patient's request to stop because of pain in the lower limbs.
TCPO2 will be measured before and during the test on the glutei and the legs. Tissue oxygenation on both lower limbs will be measured by Near Infra-Red Spectroscopy (NIRO-200NX system). Oxygen consumption will be analysed throughout the test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive treadmill test (maximum walking distance < 750m because of lower limbs muscular pain)
- •Resting systolic pressure index < 0,9 (uni- or bilateral)
- •Resting systolic blood pressure <200mmHg
- •Written informed consent
- •Affiliation to a Social Security scheme
排除标准
- •Effort hypoxemia during the selection treadmill test
- •Patient treated with metformin during the 7 days preceding the treadmill tests
- •Person who is not affiliated to a Social Security scheme or benefiting from such a scheme
- •Person in an exclusion period related to another biomedical study
- •Patient refusal / patient not having provided written informed consent
结局指标
主要结局
Walking distance during the calibrated treadmill test
时间窗: 1 week
次要结局
- Tissue oxygenation measure by Near Infra-Red Spectroscopy during the test(1 week)
- Heart rate measured 1 min and 2 min after test stop/ resting heart rate before test(1 week)
- Oxygen consumption analyse during the effort (VO2)(1 week)
- Lactate blood level at the end of the test(1 week)
- TCPO2 half-rise time measure after the test(1 week)
- Measure of the deepness of TCPO2 drop(1 week)