Clinical trial NCT02929550: Impact of Guidelines on Cardiovascular and Economic Outcomes With Focus on Lipid Lowering Drugs
Official title: Predicted Impact on Cardiovascular and Economic Outcomes of Swedish Atherosclerotic Cardiovascular Disease Guideline 2014 With Focus on Lipid Lowering Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Cardiovascular disease
Costs
Guidelines
Lipids
Myocardial infarction
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2016-10-11
Enrollment: 5304
Sex: ALL
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a cohort of 5 904 (74% men) registered in the Swedish Secondary Prevention after Heart Intensive Care Admission (SEPHIA) registry and who have had one year follow-up during 2013

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

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

Exclusion Criteria:none

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Primary outcomes:
measure: Percentage of AMI patients who have achieved target goal of LDL-cholesterol 1.8 mmol/L or not
timeFrame: AMI patients with one year follow-up year 2013
Secondary outcomes:
measure: Number of predicted CVD events gained if target LDL-cholesterol was achieved in the non-controlled group
timeFrame: Predicted number of events within a 10 year period
measure: 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
timeFrame: Predicted health care costs within a 10 year period
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Gunilla Journath, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Journath G, Hambraeus K, Hagstrom E, Pettersson B, Lothgren M. Predicted impact of lipid lowering therapy on cardiovascular and economic outcomes of Swedish atherosclerotic cardiovascular disease guideline. BMC Cardiovasc Disord. 2017 Aug 16;17(1):224. doi: 10.1186/s12872-017-0659-2.