NCT00173511

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

September 15, 2005

Status Verified

July 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Interventions

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Acute coronary syndrome before enrollment
  • Unable to receive upper endoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Disease

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ElectrocardiographyHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMonitoring, AmbulatoryMonitoring, Physiologic

Study Officials

  • Hsiu-Po Wang, MD

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

July 1, 2005

Study Completion

February 1, 2006

Last Updated

September 15, 2005

Record last verified: 2005-07

Locations