Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia
Primary Purpose
Myocardial Ischemia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
bisoprolol
amlodipine
molsidomine
acetylsalicylic acid
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring Myocardial Ischemia, Randomized Controlled Trials, Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- Documented silent myocardial ischemia type I
- At least one cardiovascular risk factor
Exclusion Criteria:
- History of cardiovascular disease
Sites / Locations
- Department of Cardiology, Hospital Lucerne
Outcomes
Primary Outcome Measures
Combination of cardiac death, non-fatal myocardial infarction, unstable angina pectoris, and revascularization
Secondary Outcome Measures
Overall mortality
Cardiac death
Non-fatal myocardial infarction
Stable and unstable angina pectoris
Revascularization
Full Information
NCT ID
NCT00382421
First Posted
September 28, 2006
Last Updated
October 10, 2006
Sponsor
Luzerner Kantonsspital
1. Study Identification
Unique Protocol Identification Number
NCT00382421
Brief Title
Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia
Official Title
Swiss Interventional Study on Silent Ischemia (SWISSI 1)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
February 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Luzerner Kantonsspital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
Myocardial Ischemia, Randomized Controlled Trials, Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bisoprolol
Intervention Type
Drug
Intervention Name(s)
amlodipine
Intervention Type
Drug
Intervention Name(s)
molsidomine
Intervention Type
Drug
Intervention Name(s)
acetylsalicylic acid
Primary Outcome Measure Information:
Title
Combination of cardiac death, non-fatal myocardial infarction, unstable angina pectoris, and revascularization
Secondary Outcome Measure Information:
Title
Overall mortality
Title
Cardiac death
Title
Non-fatal myocardial infarction
Title
Stable and unstable angina pectoris
Title
Revascularization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented silent myocardial ischemia type I
At least one cardiovascular risk factor
Exclusion Criteria:
History of cardiovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Erne, MD
Organizational Affiliation
Department of Cardiology, Hospital Lucerne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Erne, MD
Organizational Affiliation
Department of Cardiology, Hospital Lucerne
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiology, Hospital Lucerne
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19782922
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.
Results Reference
derived
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Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia
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