Clinical trial NCT00173511: Cardiovascular Events in Patients With CAD During Emergent Endoscopy for Upper Gastrointestinal Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

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

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Hsiu-Po Wang, MD
role: STUDY_DIRECTOR
References:
citation: Tseng PH, Liou JM, Lee YC, Lin LY, Yan-Zhen Liu A, Chang DC, Chiu HM, Wu MS, Lin JT, Wang HP. Emergency endoscopy for upper gastrointestinal bleeding in patients with coronary artery disease. Am J Emerg Med. 2009 Sep;27(7):802-9. doi: 10.1016/j.ajem.2008.06.018.