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Trial record 1 of 1 for:    NCT03619395
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Risc Optimisation- Acute cor5onary Syndrome (RiskOp-ACS)

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ClinicalTrials.gov Identifier: NCT03619395
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : September 6, 2019
Information provided by (Responsible Party):
Sonia Ruiz Bustillo, Parc de Salut Mar

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.

Condition or disease
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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Strategies to Optimize the Control of Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2023

Primary Outcome Measures :
  1. Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated hemoglobin recommended in the clinical guidelines [ Time Frame: 12 months ]
    LDL cholesterol and glycosylated hemoglobin levels

Secondary Outcome Measures :
  1. Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated the long term. [ Time Frame: 5 years ]
    LDL cholesterol and glycosylated hemoglobin levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with high cardiovascular risk

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619395

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Sonia Ruiz Bustillo Recruiting
Barcelona, Spain, 08003
Contact: Sonia Ruiz Bustillo, MD    0034932483118 ext 3118    sruiz@parcdesalutmar.cat   
Contact: Consol Ivern Diaz    0034932483118 ext 3118    civern@parcdesalutmar.cat   
Sponsors and Collaborators
Parc de Salut Mar
Additional Information:

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Responsible Party: Sonia Ruiz Bustillo, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03619395    
Other Study ID Numbers: ParcSM
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available within 12 months of study completion
Access Criteria: Requestors will be required to sign a Data Access Agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sonia Ruiz Bustillo, Parc de Salut Mar:
Cardiovascular Secondary prevention
Cardiovascular risk factors control
Additional relevant MeSH terms:
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Heart Diseases
Acute Coronary Syndrome
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases