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

Acute Myocardial Infarction Clinical Trial

— GuLLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929550
• Other study ID #: 2015/4:7
• Status: Completed
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: November 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5304
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 74 Years

Eligibility

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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Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Uppsala University

References & Publications (1)

Journath G, Hambraeus K, Hagström E, Pettersson B, Löthgren 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of AMI patients who have achieved target goal of LDL-cholesterol 1.8 mmol/L or not	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.	AMI patients with one year follow-up year 2013
Secondary	Number of predicted CVD events gained if target LDL-cholesterol was achieved in the non-controlled group	Number of events predicted to occur in the non-controlled group	Predicted number of events within a 10 year period
Secondary	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	Health care costs predicted to be gained if the non-controlled group achieved target LDL-cholesterol	Predicted health care costs within a 10 year period

External Links

•   Predicted impact of lipid lowering therapy on cardiovascular and economic outcomes of Swedish atherosclerotic cardiovascular disease guideline.