Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382421
Status:
COMPLETED
Last Update Posted:
2006-10-12
First Post:
2006-09-28
Brief Title:
Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia
Sponsor:
Luzerner Kantonsspital
Organization:
Luzerner Kantonsspital
Study Overview
Official Title:
Swiss Interventional Study on Silent Ischemia SWISSI 1
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None