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

NCT ID: NCT00173511

Last Updated: 2005-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-02-28

Brief Summary

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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

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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.

Conditions

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Coronary Disease

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Interventions

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24 hr Holter monitor

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Hsiu-Po Wang, MD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jyh-ming Liou, MD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Hsiu-Po Wang, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 19683108 (View on PubMed)

Other Identifiers

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9461700701

Identifier Type: -

Identifier Source: org_study_id