Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00173511
Status:
UNKNOWN
Last Update Posted:
2005-09-15
First Post:
2005-09-12
Brief Title:
Cardiovascular Events in Patients With CAD During Emergent Endoscopy for Upper Gastrointestinal Bleeding
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-07
Last Known Status:
RECRUITING
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:
Background
Upper gastrointestinal GI bleeding a common disorder encountered at emergency room may cause hypotension and tachycardia that may in turn result in myocardial ischemia in patients with coronary artery disease CAD An emergent endoscopy with hemostasis is the mainstay of management However endoscopy itself may result in myocardial ischemia Whether myocardial ischemia and arrhythmia occurs more frequently during emergent endoscopy in patients with CAD remains unknown
Objective
To determine whether the risk of myocardial ischemia and arrhythmia is increased during emergent endoscopy in patients with CAD
Method
Adult patients with documented CAD undergoing emergent endoscopy due to UGI bleeding are included Adult patients without CAD undergoing emergent endoscopy due to UGI bleeding were included as the control group The expected case numbers were 50 patients in each group Patients with terminal illness pregnancy active lung disease requiring ventilator support are excluded Before endoscopy symptoms of myocardial ischemia blood pressure heart rate O2 saturation hemogram baseline 12-lead EKG and cardiac enzyme are obtained All patients are monitored with Holter EKG since 10 minutes before endoscopy to 2 hours after the procedure Blood pressure heart rate and O2 saturation are closely monitored during the procedure Endoscopy is performed by experienced endoscopist and endoscopic hemostasis is done according to the types of lesions The duration of endoscopy types of endoscopic hemostasis and blood pressure are recorded After endoscopy symptoms of myocardial ischemia blood pressure heart rate O2 saturation hemogram baseline 12-lead EKG and cardiac enzyme are checked again
Keywords Emergent endoscopy coronary artery disease cardiovascular events
Upper gastrointestinal GI bleeding a common disorder encountered at emergency room may cause hypotension and tachycardia that may in turn result in myocardial ischemia in patients with coronary artery disease CAD An emergent endoscopy with hemostasis is the mainstay of management However endoscopy itself may result in myocardial ischemia Whether myocardial ischemia and arrhythmia occurs more frequently during emergent endoscopy in patients with CAD remains unknown
Objective
To determine whether the risk of myocardial ischemia and arrhythmia is increased during emergent endoscopy in patients with CAD
Method
Adult patients with documented CAD undergoing emergent endoscopy due to UGI bleeding are included Adult patients without CAD undergoing emergent endoscopy due to UGI bleeding were included as the control group The expected case numbers were 50 patients in each group Patients with terminal illness pregnancy active lung disease requiring ventilator support are excluded Before endoscopy symptoms of myocardial ischemia blood pressure heart rate O2 saturation hemogram baseline 12-lead EKG and cardiac enzyme are obtained All patients are monitored with Holter EKG since 10 minutes before endoscopy to 2 hours after the procedure Blood pressure heart rate and O2 saturation are closely monitored during the procedure Endoscopy is performed by experienced endoscopist and endoscopic hemostasis is done according to the types of lesions The duration of endoscopy types of endoscopic hemostasis and blood pressure are recorded After endoscopy symptoms of myocardial ischemia blood pressure heart rate O2 saturation hemogram baseline 12-lead EKG and cardiac enzyme are checked again
Keywords Emergent endoscopy coronary artery disease cardiovascular events
Detailed Description:
Expected Result and Implication If myocardial ischemia is not increased in CAD patients undergoing emergent endoscopy then this technique can be used safely in this group of patients If myocardial ischemia occurs more frequently in CAD patients undergoing emergent endoscopy we can try to analyze factors associated with increased risk such as duration of endoscopy severity of anemia or drugs used for endoscopic hemostasis Then we can try to avoid these predisposing factors and increase the safety of emergent endoscopy
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