Clinical trial NCT00382421: Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia
Official title: Swiss Interventional Study on Silent Ischemia (SWISSI 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Keywords: Myocardial Ischemia
Randomized Controlled Trials
Drug Therapy
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2006-09-29
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* History of cardiovascular disease

Primary outcomes:
measure: Combination of cardiac death, non-fatal myocardial infarction, unstable angina pectoris, and revascularization
Secondary outcomes:
measure: Overall mortality
measure: Cardiac death
measure: Non-fatal myocardial infarction
measure: Stable and unstable angina pectoris
measure: Revascularization
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Department of Cardiology, Hospital Lucerne
Study officials:
affiliation: Department of Cardiology, Hospital Lucerne
name: Paul Erne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Hospital Lucerne
name: Paul Erne, MD
role: STUDY_CHAIR
References:
citation: 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.