Viewing Study NCT03619395



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Last Modification Date: 2024-10-26 @ 12:51 PM
Study NCT ID: NCT03619395
Status: UNKNOWN
Last Update Posted: 2019-09-06
First Post: 2018-06-26

Brief Title: Risc Optimisation- Acute cor5onary Syndrome
Sponsor: Parc de Salut Mar
Organization: Parc de Salut Mar

Study Overview

Official Title: Strategies to Optimize the Control of Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome
Status: UNKNOWN
Status Verified Date: 2019-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: RiskOp-ACS
Brief 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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None