Evaluation of the Effectiveness of an Interdisciplinary Intervention After Acute Coronary Syndrome on Low-Density Lipoprotein Cholesterol Levels
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 230
- 试验地点
- 4
- 主要终点
- Proportion of patients reaching the LDL cholesterol target
研究概览
简要总结
According to the World Health Organization (WHO), cardiovascular diseases are the worldwide leading cause of death. For the French public health, cardiovascular diseases are the leading cause of death for the women and the second for men. Each year in France, approximately 120,000 acute coronary syndromes (ACS) occur, including 60,000 myocardial infarctions and more than 15,000 deaths. To prevent or reverse this process, the WHO recommends early detection of the diseases and reduce behavioral and cardiovascular risk factors.
For the patient, the European Society of Cardiology (ESC) recommends the implementation of secondary prevention measures, the lifestyle modifications and the encouragement to become an actor in the management of his health. The first year, the medical follow-up is recommended at 3, 6 and 12 months.
Since 2019, in order to reduce the impact of LDL cholesterol, the ESC has recommended that LDL cholesterol levels be lower than 0.55 g/L accompanied by a reduction of at least 50% from their initial value. In 2023, it clarified this recommendation by recommending a laboratory reassessment within 4-6 weeks after hospital discharge.
The application of these recommendations comes up against the difficulties of real life:
- The increase in the number of elderly people and people with one or more chronic diseases;
- In France, the significant regional disparities in the number of physicians;
- In 2022, six months after hospitalization for an ACS, only 21.6% of French patients had benefited from a cardiac rehabilitation program;
- Within 12 months of acute coronary syndrome, only 20% to 40% of patients achieved the LDL cholesterol targets recommended by the ESC.
Given the difficulties in implementing the recommendations, investigators believe it is essential to rethink the care pathway for post-ACS patients.
The investigator's hypothesis is that, in addition to the standard pathway, a care offering access to other healthcare professionals (advanced practice nurse, dietitian, pharmacist) should increase the proportion of patients achieving LDL cholesterol targets (LDL cholesterol < 0.55 g/L and a 50% reduction in this level compared to the baseline value) at 12 months. LDL cholesterol was selected as the endpoint because it has been proven that a reduction in LDL cholesterol corresponds to a 22% reduction in cardiovascular events.
To test this hypothesis, the investigators designed a multicenter controlled and randomized trial with two parallel arms:
- "Routine Cares" arm: Each center will program cares as usual and will schedule patient follow-up according to their wishes (cardiac rehabilitation, visits to the general practitioner and/or cardiologist).
- "Intervention" arm: In addition to routine care as described above, the patient will receive an interdisciplinary consultation one month after hospital discharge and three consultations with the IPA (3, 6, and 12 months).
In order for the conclusions of this protocol to reflect French practices, it is planned to include 230 people who have presented with acute coronary syndrome in four healthcare facilities in France (both in Paris and outside Paris).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients hospitalized for ACS (ST+ or ST-), affiliated with a social security scheme, able to understand the protocol and having signed the study consent.
排除标准
- •Patients with a complication of the ACS (mechanical complication, cardiogenic shock, very severe left ventricular dysfunction, presence of an intraventricular thrombus, complex ventricular rhythm disorder) ;
- •Proven cognitive impairment or decompensated psychological/psychiatric disorder ;
- •Any progressive inflammatory and/or infectious condition ;
- •Any orthopedic problem precluding the physical activity ;
- •Current participation in any clinical research project aimed at reducing LDL cholesterol levels ;
- •Pregnant or breastfeeding woman ;
- •Patient receiving state medical assistance ;
- •Patient under guardianship or curatorship, or any other legal protection measure ;
研究组 & 干预措施
"Standard" care pathway
Control arm:
- The French National Health Authority recommends two medical visits (at 6 and 12 month) and, if necessary, a third one (between the first and third month post-ACS) for the monitoring of the left ventricular.
- The European Society of Cardiology recommends a reassessment of the lipid profile within 4-6 weeks post-ACS.
干预措施: "Standard" care pathway (Other)
"New" care pathway
Intervention arm:
In addition to the Standard care pathway:
- One interdisciplinary consultation approximately 4 weeks post-ACS
- Three consultations with the advanced practice nurse at approximately 3 months, 6 months and 12 months post-ACS
干预措施: "New" care pathway (Behavioral)
结局指标
主要结局
Proportion of patients reaching the LDL cholesterol target
时间窗: At enrollment then at the 12th month
The target is definde as LDL cholesterol level \<0.55 g/L and \>50% reduction from baseline
次要结局
- Proportion of patients reaching the LDL cholesterol target(At enrollment then at the first month, 6th month and 12th month)
- Rate of cardiovascular events(At 12th month)
- Mortality rate and the reasons(At 6th month and 12th month)
- Number of medical (cardiologist or general practitioner) and/or paramedical (dietician, etc.) consultations(At 6th month and 12th month)
- Changes in cardiovascular risk factors(At enrollment then at the first month, 6th month and 12th month)
- Physical Activity Score(At enrollment then at the 6th month and 12th month)
- Proportion of patients who participated in a cardiac rehabilitation program(At 6th month and 12th month)
- Proportion of patients consuming toxic substances and their quantity measured(At enrollment then at the 6th month and 12th month)
- Quality of life score(At enrollment then at the 6th month and 12th month)
- Therapeutic Compliance Score(At enrollment then at the 6th month and 12th month)
- List of lipid-lowering treatments taken by patients(At enrollment then at the first month, 6th month and 12th month)
- Rehospitalization rates and the reasons(At 6th month and 12th month)
- Estimation of cost per QALY gained and cost per serious cardiac event avoided(At 12th month)
- Professional satisfaction rate by using a satisfaction scale from 0 to 10(At 12th month)