Risc Optimisation- Acute cor5onary Syndrome

Acute Coronary Syndrome Clinical Trial

— RiskOp-ACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03619395
• Other study ID #: ParcSM
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2019
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Syndrome

Locations

Country	Name	City	State
Spain	Sonia Ruiz Bustillo	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated hemoglobin recommended in the clinical guidelines	LDL cholesterol and glycosylated hemoglobin levels	12 months
Secondary	Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated the long term.	LDL cholesterol and glycosylated hemoglobin levels	5 years