Risc Optimisation- Acute cor5onary Syndrome (RiskOp-ACS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome; Ischemic Heart Disease

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Recruiting
    • Sonia Ruiz Bustillo
    • Contact: Sonia Ruiz Bustillo, MD; Phone Number: 3118 0034932483118; Email: sruiz@parcdesalutmar.cat
    • Contact: Consol Ivern Diaz; Phone Number: 3118 0034932483118; Email: civern@parcdesalutmar.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with high cardiovascular risk

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated the long term.	LDL cholesterol and glycosylated hemoglobin levels	5 years

Collaborators and Investigators

• Sponsor: Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Cardiovascular Secondary prevention; Cardiovascular risk factors control
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: ParcSM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: Data will be available within 12 months of study completion
• IPD Sharing Access Criteria: Requestors will be required to sign a Data Access Agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No