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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173511
First received: September 12, 2005
Last updated: NA
Last verified: July 2005
History: No changes posted
  Purpose

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


Condition Intervention
Coronary Disease
Device: 24 hr Holter monitor

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 100
Study Start Date: July 2005
Estimated Study Completion Date: February 2006
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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00173511

Contacts
Contact: Jyh-ming Liou, MD 886-2-23123456 ext 5695 dtmed046@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Hsiu-Po Wang, MD    886-2-23123456 ext 5695    whp@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Hsiu-Po Wang, MD National Taiwan University Hospital
  More Information

No publications provided by National Taiwan University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00173511     History of Changes
Other Study ID Numbers: 9461700701
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Gastrointestinal Hemorrhage
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014