Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.
Trials. 2021 Mar 8;22(1):192. doi: 10.1186/s13063-021-05099-7.
Obstruction of coronary microcirculation can lead to myocardial ischemia and poor prognosis. Salvianolate exerts cardiovascular protection at cellular levels. However, no studies have confirmed the effect of salvianolate on stable coronary heart disease (CHD) with high fractional flow reserve (FFR) and myocardial microcirculatory disturbances.
METHODS/DESIGN: This study will enroll 78 patients who have stable coronary disease with 50 to 70% stenosis in major coronary arteries and whose FFR > 0.80 and index of microcirculatory resistance (IMR) > 25. Patients will be randomly divided into the salvianolate group or the placebo group. After above evaluations, salvianolate 200 mg will be intravenously dripped immediately for the next 30 min and subsequent 7 days in the salvianolate group, and matching 0.9% normal saline will be arranged in the placebo group. IMR will be reevaluated in immediate phase after first 30 min of salvianolate or placebo treatment. The primary end point will be the IMR change in this phase, and the secondary end points will be the total ischemic burden assessed by the Seattle angina scale, quality of life scale, Holter electrocardiography, and 6-min walk test after 7 days before discharge.
This study will firstly clarify the improvement effect of salvianolate on coronary microcirculation and provide an effective treatment method for stable CHD patients with high FFR and myocardial microcirculatory disturbance.
Chinese Clinical Trial Registry ChiCTR1800018772 . Registered on 9 October 2018 and updated on 2 March 2020.
冠状动脉微循环阻塞可导致心肌缺血和预后不良。丹参多酚酸盐在细胞水平发挥心血管保护作用。然而，尚无研究证实丹参多酚酸盐对高血流储备分数（FFR）和心肌微循环障碍的稳定性冠心病（CHD）的疗效。
方法/设计：本研究将纳入 78 例主要冠状动脉狭窄 50%~70%且 FFR>0.80 及微血管阻力指数（IMR）>25 的稳定型冠心病患者。患者将被随机分为丹参多酚酸盐组或安慰剂组。评估后，丹参多酚酸盐组立即静脉滴注丹参多酚酸盐 200mg，持续 30min，随后连续 7d；安慰剂组给予等容量 0.9%生理盐水。在首次滴注 30min 后即刻评估 IMR。主要终点为该阶段的 IMR 变化，次要终点为西雅图心绞痛量表评估的总缺血负荷、生活质量量表、动态心电图和出院前 7d 的 6min 步行试验。
本研究将首次阐明丹参多酚酸盐对冠状动脉微循环的改善作用，为高 FFR 和心肌微循环障碍的稳定性 CHD 患者提供有效的治疗方法。
中国临床试验注册中心 ChiCTR1800018772 。于 2018 年 10 月 9 日注册，2020 年 3 月 2 日更新。
