NCT00679237

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
9 months until next milestone

First Posted

Study publicly available on registry

May 16, 2008

Completed
11.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

12.3 years

First QC Date

July 5, 2007

Last Update Submit

March 16, 2021

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • New cardiovascular events (MACE)

    3 years

Study Arms (2)

Multifactorial intervention

ACTIVE COMPARATOR

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

Behavioral: smoking cessationDrug: betablocker, diuretics, ACEI, ARB,Drug: statins, ezetimibeBehavioral: trainingBiological: influenza vaccineDrug: metformin, glimepiride, insulinBehavioral: weight reduction

Control

NO INTERVENTION

no intervention

Interventions

smoking cessationBEHAVIORAL

NRT and varenicline

Multifactorial intervention
betablocker, diuretics, ACEI, ARB,DRUG

blood pressure control according to ESC guidelines

Multifactorial intervention
statins, ezetimibeDRUG

Cholesterol reduction according to ESC guidelines

Multifactorial intervention
trainingBEHAVIORAL

daily walking

Multifactorial intervention
influenza vaccineBIOLOGICAL

vaccine (FLuarix, Influvac etc)

Multifactorial intervention
metformin, glimepiride, insulinDRUG

s.glucose control according to ESC guidelines

Multifactorial intervention
weight reductionBEHAVIORAL

diet tips

Multifactorial intervention

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute myocardial infarction, CABG or PCI

You may not qualify if:

  • Age \< 18 and age \> 80
  • pregnant
  • critical illness
  • drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sorlandet Hospital

Arendal, Norway

Location

Related Publications (4)

  • 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.

    PMID: 39323439DERIVED

  • 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.

    PMID: 37710178DERIVED

  • 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.

    PMID: 37118703DERIVED

  • 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.

    PMID: 34915839DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

DiureticsAngiotensin-Converting Enzyme InhibitorsHydroxymethylglutaryl-CoA Reductase InhibitorsEzetimibeInfluenza VaccinesMetforminglimepirideInsulin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionAnticholesteremic AgentsHypolipidemic AgentsAntimetabolitesLipid Regulating AgentsTherapeutic UsesAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsViral VaccinesVaccinesBiological ProductsComplex MixturesBiguanidesGuanidinesAmidinesOrganic ChemicalsProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Serena Tonstad, dr.med.

    Ullevaal University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sorlandet Hospital HF

Study Record Dates

First Submitted

July 5, 2007

First Posted

May 16, 2008

Study Start

September 1, 2007

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

NO(1)