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Evaluation of Patients With Non-cardiac Chest Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00476398
First Posted: May 22, 2007
Last Update Posted: September 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Brigham and Women's Hospital
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Patients With Non-cardiac Chest Pain Using PillCam Eso - a Wireless Imaging Capsule of the Esophagus.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • endoscopy for evaluating the prevalence of esophago-gastric lesions in patients [ Time Frame: 60 day ]

Enrollment: 40
Study Start Date: January 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Diagnostic capsule endoscopy
Patient with non-cardiac chest pain will undergo capsule endoscopy
Procedure: Capsule endoscopy
Patient will undergo a capsule endoscopy for the evaluation of their chest pain.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476398


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

Responsible Party: Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00476398     History of Changes
Other Study ID Numbers: 2005P001321
First Submitted: May 21, 2007
First Posted: May 22, 2007
Last Update Posted: September 10, 2009
Last Verified: September 2009

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Chest Pain
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms


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