Evaluation of Patients With Non-cardiac Chest Pain
Primary Purpose
Non-Cardiac Chest Pain, Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Capsule endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-Cardiac Chest Pain focused on measuring Capsule endoscopy, Wireless imaging, esophagus, stomach
Eligibility Criteria
Inclusion Criteria:
- age 18 to 80 years
- negative cardiac evaluation in the emergency department
- pre-established access to a primary care provider
- ability to give informed consent
Exclusion Criteria:
- known history of ischemic heart disease
- proton pump inhibitor therapy
- known or suspected obstructions or strictures in the gastrointestinal tract, including a history of Crohn's disease, gastrointestinal surgery other than cholecystectomy or appendectomy.
- permanent pacemakers/defibrillators or other implantable wireless devices
- known pregnancy
- unstable medical conditions
- inability to follow instructions
- active psychiatric conditions that preclude participation in the study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Diagnostic capsule endoscopy
Arm Description
Patient with non-cardiac chest pain will undergo capsule endoscopy
Outcomes
Primary Outcome Measures
endoscopy for evaluating the prevalence of esophago-gastric lesions in patients
Secondary Outcome Measures
Full Information
NCT ID
NCT00476398
First Posted
May 21, 2007
Last Updated
September 8, 2009
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00476398
Brief Title
Evaluation of Patients With Non-cardiac Chest Pain
Official Title
Evaluation of Patients With Non-cardiac Chest Pain Using PillCam Eso - a Wireless Imaging Capsule of the Esophagus.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to find out how common diseases of the esophagus can cause chest pain. Gastroesophageal reflux disease (GERD), commonly known as heartburn, is a common cause of chest pain in patients that do not have heart problems. The study test is called PillCam Eso, it is a small, pill sized capsule that has a small camera inside it. The camera will take pictures of the esophagus and the stomach as it goes down. Findings of the PillCam Eso will be compared to findings during conventional upper endoscopy.
Detailed Description
Non-cardiac chest pain (NCCP) is defined by recurrent episodes of retrosternal chest pain in the absence of significant cardiovascular disease after a thorough cardiac evaluation. It accounts for 2-5% of all emergency department visits. Studies examining the prevalence of esophago-gastric lesions in patients with NCCP referred to gastroenterologists have found esophagitis, esophageal ulcers, hiatal hernias, gastritis, and gastric ulcers in 62% of patients. Advances in endoscopic technologies, particularly, the introduction of the wireless video-capsule (PillCam Eso) allows for the possibility of direct visualization of the upper gastrointestinal tract in the emergency department. During capsule endoscopy, a patient will swallow a pill-sized video-capsule, the wireless images of the gastrointestinal tract are transmitted to a computer. Findings of the PillCam Eso will be then compared to findings during conventional upper endoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Cardiac Chest Pain, Gastroesophageal Reflux Disease
Keywords
Capsule endoscopy, Wireless imaging, esophagus, stomach
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic capsule endoscopy
Arm Type
No Intervention
Arm Description
Patient with non-cardiac chest pain will undergo capsule endoscopy
Intervention Type
Procedure
Intervention Name(s)
Capsule endoscopy
Intervention Description
Patient will undergo a capsule endoscopy for the evaluation of their chest pain.
Primary Outcome Measure Information:
Title
endoscopy for evaluating the prevalence of esophago-gastric lesions in patients
Time Frame
60 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 to 80 years
negative cardiac evaluation in the emergency department
pre-established access to a primary care provider
ability to give informed consent
Exclusion Criteria:
known history of ischemic heart disease
proton pump inhibitor therapy
known or suspected obstructions or strictures in the gastrointestinal tract, including a history of Crohn's disease, gastrointestinal surgery other than cholecystectomy or appendectomy.
permanent pacemakers/defibrillators or other implantable wireless devices
known pregnancy
unstable medical conditions
inability to follow instructions
active psychiatric conditions that preclude participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia J. Liu, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Patients With Non-cardiac Chest Pain
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