Cardiovascular Events in Patients With CAD During Emergent Endoscopy for Upper Gastrointestinal Bleeding

Coronary Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00173511
• Other study ID #: 9461700701
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: July 2005
• Est. completion date: February 2006

Study information

• Verified date: July 2005
• Source: National Taiwan University Hospital
• Contact: Jyh-ming Liou, MD
• Phone: 886-2-23123456
• Email: dtmed046[@]ha.mc.ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Acute coronary syndrome before enrollment

• Unable to receive upper endoscopy

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• 24 hr Holter monitor

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,