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临床试验/NCT03619395
NCT03619395Unknown不适用

Strategies to Optimize the Control of Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome

Parc de Salut Mar1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated hemoglobin recommended in the clinical guidelines

研究概览

简要总结

This study evaluates the percentage of patients that reach the objective levels of LDL cholesterol, glycosylated hemoglobin and blood pressure recommended by clinical guidelines after an acute coronary syndrome, following strategies of pharmacological optimization based on algorithms. The investigators hypothesize that the use of algorithms designed and protocolized within a cardiac rehabilitation program after an ACS to optimize pharmacological treatment is effective and safe to improve the control of risk factors in patients with high cardiovascular risk.

详细描述

Despite the evidence, lipid-lowering pharmacological intervention in secondary prevention remains insufficient. These data are also confirmed in a study conducted in our environment where of a total of 423 high-risk patients only 29% had an optimal control of LDL-C levels and 36% of glycated hemoglobin levels. A possible explanation is the so-called therapeutic inertia defined as the failure of physicians to initiate or intensify an indicated therapy. The inadequate treatment of the risks factors in the high-risk population increases morbidity and mortality, so it is very relevant to find strategies that improve adherence to clinical practice guidelines.

Prospective observational study of a patient population after ACS that will be compared with a historical cohort. All participants will give informed consent before initiating procedures within the cardiac rehabilitation program.

Primary outcome: To analyze the percentage of patients that reach the objective levels of LDL cholesterol and glycosylated hemoglobin recommended by clinical guidelines following pharmacological optimization protocols based on algorithms developed for this study. These results will be compared with the historical cohort of our hospital (usual practice) Secondary outcome: to analyze if the results of the intensive intervention during the first year are maintained in the long term (5 years)

Baseline clinical, analytical, echocardiographic, coronary anatomy and pharmacological therapy data will be collected. After six weeks of lipid-lowering treatment, a first analytical control will be carried out and, following the specific algorithm designed for this study, oral pharmacological treatment will be adapted if the LDL-C target level is not met. After any change in therapy, a new analytical control will be performed after 8 weeks. Diabetic patients will also undergo a baseline analytical study, if the glycosylated hemoglobin values are not in the range recommended by the clinical practice guidelines, pharmacological treatment optimization will be initiated following the algorithm designed for the study. After three months of treatment, a new control and optimization of the treatment will be carried out according to the protocol designed.

A follow-up will be carried out after 6, 12 months and 5 years

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients hospitalized with a diagnosis of acute coronary syndrome who have signed informed consent

排除标准

  • patients with disability or refusal to sign informed consent or who have comorbidities with a life expectancy of less than 1 year

结局指标

主要结局

Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated hemoglobin recommended in the clinical guidelines

时间窗: 12 months

LDL cholesterol and glycosylated hemoglobin levels

次要结局

  • Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated the long term.(5 years)

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sonia Ruiz Bustillo

MD

Parc de Salut Mar

研究点 (1)

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