Intensive Blood PRessure Control in Patients With Acute Type B AortIc Dissection (RAID): Study Protocol for Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- composite in-hospital adverse outcome
研究概览
简要总结
Aortic dissection (AD) aneurysm is a common catastrophic aortic disease in clinical setting. Conservative therapy of heart rate and blood pressure control in the acute phase is the essential treatment as guidelines recommended. Nevertheless, there is no unanimous optimal target for blood pressure in patients with AD so far. The American Heart Association and the Canadian Cardiovascular Society recommend the blood pressure should be controlled to lower than 140/90mmHg, while for patients with diabetes or chronic renal failure, the blood pressure target should be no less than 130/80 mmHg. Recently, the Japanese Circulation Society recommended that the blood pressure should be controlled to no less than 130mmHg. However, there was few large-scale, randomized, controlled studies reported on the effect of different blood pressure control levels on the prognosis of patients with AD. Hence, the intensive control of blood pressure to <120 mmHg, compared to <140 mmHg, may improve the patients' outcome. Thus, in this study, the effect of intensive blood pressure control (<120mmHg) with conventional blood pressure control (<140mmHg) on the prognosis of ABAD patients will be compared, and to identify the therapeutic efficacy of intensive blood pressure control on the ABAD patients.
详细描述
Aortic dissection (AD) aneurysm is a common catastrophic aortic disease in clinical setting. In the U.S., the prevalence is approximate 2.9-3.5 cases/100000 persons per year, with recent evidence showing an increasing incidence of up to 14 cases per 100000 patients per year. AD aneurysm can be classified into the types of Stanford A and B based on whether the ascending aorta was being involved. For acute type B aortic dissection (ABAD), which is generally accounted for one thirds of all aortic dissection and is especially more common among Chinese due to the suboptimal control of blood pressure. Optimal treatment of ABAD from symptom onset remains uncertain. Conservative therapy of heart rate and blood pressure control in the acute phase is the essential treatment for patient without serious complications such as concurrent mesenteric artery or lower limb arterial embolism. The long-term survival of ABAD is still low though great improved in medication optimization and surgical repair technique in the past decades. It was reported that 5-year and 10-year survival rates for ABAD were 60% and 35% respectively. As the development of minimally invasive techniques in recent years, the endovascular repair procedure has become a routine procedure in the treatment of patient with ABAD, this rendered an improved prognosis with a 5-year survival rate close to 80%.
Hypertension is well known as the most common cause for AD. The statistics from International Registry of Acute Aortic Dissection (IRAD) demonstrated that 72.1% of AD patients had a history of hypertension. The hypertension may aggravate hematoma expansion and results in serious consequences. Therefore, effectively blood pressure control may alleviate the severe pain caused by acute AD and lessen the progression of arterial dissection. The control of hypertension is the primary treatment for acute aortic dissection, and should be maintained throughout the entire treatment. Currently, all guidelines recommended to decline the transaortic pressure via controlling the heart rate and blood pressure for AD patient in acute phase. Theoretically, to control the blood pressure to the minimal level meeting the sufficient end-organ perfusion can decrease the risk of vessel rupture as much as possible. Whereas, too much low blood pressure target may increase the mortality of patients. Powell and his colleague found when the minimum blood pressure increased by 10mmHg (vs. <70 mmHg, maximal to 120 mmHg) for AD patients, the risk of death decreased by 12% (OR = 0.88, P <0.001).
Nevertheless, there is no unanimous optimal target for blood pressure in patients with AD so far. The American Heart Association and the Canadian Cardiovascular Society recommend the blood pressure should be controlled to lower than 140/90mmHg, while for patients with diabetes or chronic renal failure, the blood pressure target should be no less than 130/80 mmHg. Recently, the Japanese Circulation Society recommended that the blood pressure should be controlled to no less than 130mmHg. Hence, the intensive control of blood pressure to <120 mmHg, compared to <140 mmHg, may improve the patients' outcome. Thus, in this study, the effect of intensive blood pressure control (<120mmHg) with conventional blood pressure control (<140mmHg) on the prognosis of ABAD patients will be compared.
Methods Study design and setting The study was a prospective randomized controlled trial that will recruit a maximal of 360 patients in eight tertiary Chinese hospitals over 2 years. All patients with new diagnosed ABAD in the participating hospitals will be screened for potential eligibility. The study was approved by the ethics committee of the hospitals (20160920-9). Written informed consents will be signed by the patients or their legally authorized representatives. The study was registered in the website of ClinicalTrial.gov .
Sites and patients Doctors from eight hospitals attended the kick-off meeting held in Courtyard Marriott, Hangzhou, March 19th, 2016, and discussed the research protocol and details. The amended research protocol was passed according to revised discussion results and the agreement of all participating units. The methods of blood pressure measurement and the apparatus used are unified. All hospitals will adopt similar non-invasive blood pressure monitoring method and unified monitoring frequency to observe whether the blood pressure is controlled within the target range in two groups. Likewise, the blood pressure target after discharge was maintained at the same levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with Stanford type B acute aortic dissection and systolic blood pressure>160mmHg
排除标准
- •Age <18 years,
- •In pregnancy,
- •Diagnosis of aortic dissection was made 48 hours or more prior,
- •Dissection due to aortic intramural hematoma or penetrating atherosclerotic ulcer,
- •With history of previous surgical or interventional endovascular treatment for aortic diseases,
- •With traumatic aortic injury,
- •With history of cerebrovascular accident, brain surgery, chronic renal insufficiency, and mesenteric vascular thrombosis or dissection,
- •AD patient concomitant with new cerebral infarction, or ischemic mesenteric artery or lower limb arteries which requiring urgent surgical interventions,
- •With obvious contraindications for antihypertensive therapy, such as severe carotid stenosis, cerebral infarction in acute phase ,
- •Pathogenesis of the dissection was due to congenital aortic hypoplasia, such as Marfan syndrome, connective tissue diseases.
研究组 & 干预措施
Intensive BP control (<120mmHg)
Urapidil Hydrochloride Injection (100-400ug/min) or other antihypertensive agents to decrease the BP to < 120 mm Hg
干预措施: Urapidil Hydrochloride Injection (Drug)
Conventional BP control (120-140mmHg)
Urapidil Hydrochloride Injection (100-400ug/min) or other antihypertensive agents to decrease the BP to 120-140 mm Hg
干预措施: Urapidil Hydrochloride Injection (Drug)
结局指标
主要结局
composite in-hospital adverse outcome
时间窗: From date of randomization until the date of death from any cause，or permanent paraplegia or semi- paralysis during the hospitalization, and renal failure requiring hemodialysis at discharge, whichever came first, assessed up to 3 months
including death, permanent paraplegia or semi- paralysis during the hospitalization, and renal failure requiring hemodialysis at discharge
次要结局
- mortality(6-month and 1-year after onset of the dissection)
- ICU length of stay(From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 3 months)
- re-operation or another endovascular intervention for the same problem(From date of first intervention until the date of second intervention, assessed up to 12 months)
研究者
Jian-cang Zhou M.D.
Principal Investigator
Sir Run Run Shaw Hospital