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

NCT ID: NCT02929550

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5304 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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

Conditions

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Acute Myocardial Infarction

Keywords

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Cardiovascular disease Costs Guidelines Lipids Myocardial infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Well-controlled cohort (LDL-C ≤ 1.8 mmol/L)

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

Well-controlled

Intervention Type OTHER

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

Non-controlled cohort

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 and with not well-controlled LDL-C

No interventions assigned to this group

Interventions

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Well-controlled

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

Intervention Type OTHER

Other Intervention Names

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Non-controlled

Eligibility Criteria

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Exclusion Criteria

\-
Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Gunilla Journath

Postdoc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunilla Journath, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

References

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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.

Reference Type RESULT
PMID: 28814290 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5559790/pdf/12872_2017_Article_659.pdf

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

Other Identifiers

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2015/4:7

Identifier Type: -

Identifier Source: org_study_id