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Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia

NCT ID: NCT00382421

Last Updated: 2006-10-12

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

Study Classification

INTERVENTIONAL

Study Start Date

1992-02-29

Study Completion Date

2006-04-30

Brief Summary

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There is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), and, particularly, on a possible benefit of medical therapy in such patients. SWISSI 1 therefore recruits totally asymptomatic subjects older than 40 years of age without any history of CAD but one cardiovascular risk factor with documented silent ischemia. Participants are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.

Detailed Description

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Although there is still controversy regarding why ischemic episodes are symptomatic in some patients and completely asymptomatic in others, it is now widely accepted that silent ischemia, like symptomatic episodes, negatively affects prognosis. Silent ischemia may occur in totally asymptomatic patients without (type I) or with a history (type II) of an ischemic cardiac event and coexists with symptomatic episodes in many patients (type III). However, there is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), i.e. silent ischemia type I, and, particularly, on a possible benefit of medical therapy in such patients. Reasons lie in the difficulty to identify such patients and their expected low event rates implying that large patient populations and/or long follow-up periods would be necessary to come to definite conclusions. Still, to address this problem, we perform SWISSI 1 which includes totally asymptomatic subjects older than 40 years of age without any history of CAD but one cardiovascular risk factor with documented silent ischemia. They are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.

Conditions

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Myocardial Ischemia

Keywords

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Myocardial Ischemia Randomized Controlled Trials Drug Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bisoprolol

Intervention Type DRUG

amlodipine

Intervention Type DRUG

molsidomine

Intervention Type DRUG

acetylsalicylic acid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented silent myocardial ischemia type I
* At least one cardiovascular risk factor

Exclusion Criteria

* History of cardiovascular disease
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luzerner Kantonsspital

OTHER

Sponsor Role lead

Principal Investigators

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Paul Erne, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Hospital Lucerne

Paul Erne, MD

Role: STUDY_CHAIR

Department of Cardiology, Hospital Lucerne

Locations

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Department of Cardiology, Hospital Lucerne

Lucerne, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

References

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Schoenenberger AW, Jamshidi P, Zuber M, Stuck AE, Pfisterer M, Erne P. Coronary artery disease is common in asymptomatic patients with signs of myocardial ischemia. Eur J Intern Med. 2009 Oct;20(6):607-10. doi: 10.1016/j.ejim.2009.04.001. Epub 2009 May 8.

Reference Type DERIVED
PMID: 19782922 (View on PubMed)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id