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

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.

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Key information

Conditions

Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

Up to 74 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Well-controlled

Other

Both groups got treatment but well-controlled reached target of LDL-C<1.8 mmol/l

Other names: Non-controlled

Primary outcomes

Percentage of AMI patients who have achieved target goal of LDL-cholesterol 1.8 mmol/L or not

Time frame: 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 outcomes

Number of predicted CVD events gained if target LDL-cholesterol was achieved in the non-controlled group

Time frame: Predicted number of events within a 10 year period

Number of events predicted to occur in the non-controlled group
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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

Uppsala University

Registry information

Official study title

Predicted Impact on Cardiovascular and Economic Outcomes of Swedish Atherosclerotic Cardiovascular Disease Guideline 2014 With Focus on Lipid Lowering Treatment

Acronym: GuLLD

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Oct 11, 2016
Registry last updated: Nov 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed