Evaluation of Patients With Non-Cardiac Chest Pain - Full Text View

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
Study 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 January 16, 2009