ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Evaluation of Patients With Non-Cardiac Chest Pain

This study is currently recruiting participants.
Verified by Brigham and Women's Hospital, May 2007

Sponsored by: Brigham and Women's Hospital
Information provided by: Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00476398
  Purpose

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.


Condition Intervention Phase
Non-Cardiac Chest Pain
Gastroesophageal Reflux Disease
Procedure: Capsule endoscopy
Phase IV

MedlinePlus related topics:   Chest Pain    Endoscopy    GERD   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:   Evaluation of Patients With Non-Cardiac Chest Pain Using PillCam Eso - a Wireless Imaging Capsule of the Esophagus.

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Determination of the diagnostic accuracy of PillCam Eso compared to conventional
  • endoscopy for evaluating the prevalence of esophago-gastric lesions in patients
  • with non-cardiac chest pain in the emergency department.

Estimated Enrollment:   200
Study Start Date:   January 2006

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.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476398

Contacts
Contact: Julia J. Liu, MD     617-378-5327     julia.liu@ualberta.ca    
Contact: John R. Saltzman, MD     617-732-7429     jsaltzman@partners.org    

Locations
United States, Massachusetts
Brigham and Women's Hospital     Recruiting
      Boston, Massachusetts, United States, 02115

Sponsors and Collaborators
Brigham and Women's Hospital

Investigators
Principal Investigator:     Julia J. Liu, MD     Brigham and Women's Hospital    
  More Information


Study ID Numbers:   2005P001321
First Received:   May 21, 2007
Last Updated:   May 21, 2007
ClinicalTrials.gov Identifier:   NCT00476398
Health Authority:   United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Capsule endoscopy  
Wireless imaging  
esophagus  
stomach  

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Signs and Symptoms
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Pain
Esophageal Diseases
Gastroesophageal Reflux
Chest Pain

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers