Abstract
BackgroundObstruction 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/designThis 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.DiscussionThis 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.Trial registrationChinese Clinical Trial Registry ChiCTR1800018772. Registered on 9 October 2018 and updated on 2 March 2020
Highlights
Obstruction of coronary microcirculation can lead to myocardial ischemia and poor prognosis
Obstruction of coronary microcirculation can lead to myocardial ischemia [5], significantly affecting the patients’
No studies have been conducted to verify the efficacy of salvianolate against coronary microcirculatory disturbance of coronary heart disease (CHD) from the perspective of Index of microcirculatory resistance (IMR)
Summary
Traditional methods for improving angina include drug therapy, interventional therapy, and coronary artery bypass grafting. The European Society of Cardiology 2013 guideline for stable CHD clearly incorporates coronary microcirculatory disorder into the field of stable CHD and proposes the concept of CHD patients with ischemic symptoms but no evidence of obstruction [22]. The study could only be designed based on the aforementioned limitations, we can still evaluate the effect of intravenous salvianolate infusion on IMR in stable CHD patients with high FFR and myocardial microcirculatory disturbance and test the improvement of the clinical symptoms of CHD patients with stable microcirculatory disturbance. This study will clarify the effect of salvianolate on coronary microcirculation and provide an effective treatment for patients with stable CHD with high FFR and myocardial microcirculatory disturbances.
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