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Effects of salvianolate on microcirculatory disturbance in patients with stable coronary heart disease: study
Zhanlu Li1, Yi Luan1, Min Wang1
1Department 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.
Insights
This study investigates salvianolate for stable coronary heart disease (CHD) with microcirculatory dysfunction. It aims to confirm salvianolate improves coronary microcirculation in patients with high fractional flow reserve (FFR).
Area of Science:
- Cardiology
- Vascular Biology
- Pharmacology
Background:
- Coronary microcirculation obstruction leads to myocardial ischemia and poor outcomes.
- Salvianolate demonstrates cellular cardiovascular protective effects.
- The impact of salvianolate on stable coronary heart disease (CHD) with high fractional flow reserve (FFR) and microcirculatory disturbances remains unconfirmed.
Purpose of the Study:
- To evaluate the efficacy of salvianolate in improving coronary microcirculation in patients with stable CHD.
- To assess the effect of salvianolate on myocardial microcirculatory resistance (IMR) in patients with high FFR.
- To provide a potential new treatment for stable CHD patients experiencing microcirculatory disturbances.
Main Methods:
- A randomized controlled trial involving 78 patients with stable coronary disease, high FFR (>0.80), and elevated IMR (>25).
- Patients were randomized to receive either salvianolate (200 mg IV) or placebo for 7 days.
- The primary endpoint was the change in IMR after initial treatment; secondary endpoints included angina burden, quality of life, and exercise capacity.
Main Results:
- The study is designed to measure the change in the index of microcirculatory resistance (IMR) as the primary outcome.
- Secondary outcomes will assess improvements in Seattle angina scale, quality of life, Holter ECG, and 6-minute walk test.
- Results are pending completion of the trial and data analysis.
Conclusions:
- This study is expected to be the first to clarify salvianolate's effect on coronary microcirculation in specific CHD patient populations.
- Findings may establish salvianolate as an effective therapeutic option for stable CHD with high FFR and microcirculatory impairment.
Background:
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.
Discussion:
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.
Trial Registration:
Chinese Clinical Trial Registry ChiCTR1800018772 . Registered on 9 October 2018 and updated on 2 March 2020.
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