Impact of Guidelines on Cardiovascular and Economic Outcomes With Focus on Lipid Lowering Drugs

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Other: Well-controlled

• Registration Number: NCT02929550
• Lead Sponsor: Karolinska Institutet

Brief Summary

Methods: All patients \<75 years registered in the Swedish Secondary Prevention after Heart Intensive care Admission registry (SEPHIA), will be followed-up within one year post-myocardia infarction (MI). The REACH risk prediction and a calibrated model for recurrent cardiovascular disease (CVD) events and death will be used to estimate base case, and calibrated CVD outcomes based on gender-specific risk factors. The predicted impact of the LDL-C reduction on the risk of CVD will be based on Cholesterol Treatment Trialists´ Collaboration findings.

Detailed Description

SWEDEHEART is a Swedish national registry consisting of several sub registries in which patients with acute coronary syndrome are prospectively registered. Patient characteristics, hospital treatments, drug treatments at discharge, and outcome for patients consecutively included and treated at all Swedish coronary care units are collected in this registry.SEPHIA is a sub registry collecting data on secondary prevention and cardiac rehabilitation. Follow-up are registered at six to ten weeks and at 12 to14 months post MI by office visits or phone. Around 80 % of all Swedish acute myocardial infarction (AMI) patients below the age of 75 years are included in this register.

In this study, a cohort of 5 904 (74% men) registered in the SEPHIA registry and who had one year follow-up during 2013, will be included. Data are aggregated and delivered from the SWEDEHEART/SEPHIA national registry. All patients were informed about their participation in the registry, the follow-up, and their right to decline participation. No written consent was obtained

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-01
• Study Completion: 2016-04
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5304

Inclusion Criteria

All patients with acute myocardial infarction registered in the SEPHIA registry and who had one year follow-up during 2013 -

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Exclusion Criteria

none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Well-controlled cohort (LDL-C ≤ 1.8 mmol/L)	Well-controlled	Individuals in the Swedish Secondary Prevention after Heart intensive care Admission (SEPHIA) is a sub register within SWEDEHEART collecting data on secondary prevention and cardiac rehabilitation with well-controlled LDL-cholesterol

Primary Outcome Measures

Name	Time	Method
Percentage of AMI patients who have achieved target goal of LDL-cholesterol 1.8 mmol/L or not	AMI patients with one year follow-up year 2013	Treatment gap will be analysed in well-controlled (LDL-C ≤1.8 mmol/L) and non-controlled ( LDL-C \>1.8 mmol/L) cohort in men and women separately.

Secondary Outcome Measures

Name	Time	Method
Health care costs in SEK saved, due to number of predicted CVD events gained if target LDL-cholesterol was achieved in the non-controlled group	Predicted health care costs within a 10 year period	Health care costs predicted to be gained if the non-controlled group achieved target LDL-cholesterol
Number of predicted CVD events gained if target LDL-cholesterol was achieved in the non-controlled group	Predicted number of events within a 10 year period	Number of events predicted to occur in the non-controlled group