Risk Reduction in Coronary Heart Disease

NCT ID: NCT00679237

Last Updated: 2021-03-17

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

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2019-12-31

Brief Summary

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Study hypothesis: Multifactorial risk reduction in coronary heart disease can reduce the risk of new coronary heart disease and death

Detailed Description

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Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Multifactorial intervention

Smoking cessation betablocker, diuretics, ACEI, ARB, statins, ezetimibe training influenza vaccine weight reduction metformin, glimepiride, insulin

Group Type ACTIVE_COMPARATOR

smoking cessation

Intervention Type BEHAVIORAL

NRT and varenicline

betablocker, diuretics, ACEI, ARB,

Intervention Type DRUG

blood pressure control according to ESC guidelines

statins, ezetimibe

Intervention Type DRUG

Cholesterol reduction according to ESC guidelines

training

Intervention Type BEHAVIORAL

daily walking

influenza vaccine

Intervention Type BIOLOGICAL

vaccine (FLuarix, Influvac etc)

metformin, glimepiride, insulin

Intervention Type DRUG

s.glucose control according to ESC guidelines

weight reduction

Intervention Type BEHAVIORAL

diet tips

Control

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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smoking cessation

NRT and varenicline

Intervention Type BEHAVIORAL

betablocker, diuretics, ACEI, ARB,

blood pressure control according to ESC guidelines

Intervention Type DRUG

statins, ezetimibe

Cholesterol reduction according to ESC guidelines

Intervention Type DRUG

training

daily walking

Intervention Type BEHAVIORAL

influenza vaccine

vaccine (FLuarix, Influvac etc)

Intervention Type BIOLOGICAL

metformin, glimepiride, insulin

s.glucose control according to ESC guidelines

Intervention Type DRUG

weight reduction

diet tips

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* acute myocardial infarction, CABG or PCI

Exclusion Criteria

* Age \< 18 and age \> 80
* pregnant
* critical illness
* drug abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sissel Ledang

Sorlandet Hospital HF

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serena Tonstad, dr.med.

Role: STUDY_CHAIR

Ullevaal University Hospital

Locations

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Sorlandet Hospital

Arendal, , Norway

Site Status

Countries

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Norway

References

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Kaldal A, Tonstad S, Jortveit J. Self-reported smoking status and exhaled carbon monoxide in secondary preventive follow-up after coronary heart events: Do our patients tell the truth? Tob Prev Cessat. 2024 Sep 25;10. doi: 10.18332/tpc/191843. eCollection 2024.

Reference Type DERIVED
PMID: 39323439 (View on PubMed)

Kaldal A, Tonstad S, Jortveit J. Sex differences in secondary preventive follow-up after coronary heart events. BMC Cardiovasc Disord. 2023 Sep 14;23(1):459. doi: 10.1186/s12872-023-03483-6.

Reference Type DERIVED
PMID: 37710178 (View on PubMed)

Kaldal A, Tonstad S, Jortveit J. Association of Troponin T measurements with long-term outcomes in patients with coronary artery disease participating in a secondary prevention trial. BMC Cardiovasc Disord. 2023 Apr 28;23(1):210. doi: 10.1186/s12872-023-03249-0.

Reference Type DERIVED
PMID: 37118703 (View on PubMed)

Kaldal A, Tonstad S, Jortveit J. Long-term hospital-based secondary prevention of coronary artery disease: a randomized controlled trial. BMC Cardiovasc Disord. 2021 Dec 16;21(1):600. doi: 10.1186/s12872-021-02426-3.

Reference Type DERIVED
PMID: 34915839 (View on PubMed)

Other Identifiers

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S-07041a (REK)

Identifier Type: -

Identifier Source: org_study_id

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