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Evaluation of Patients With Non-cardiac Chest Pain

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.
 
ClinicalTrials.gov Identifier: NCT00476398
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : September 10, 2009
Sponsor:
Information provided by:
Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE May 21, 2007
First Posted Date  ICMJE May 22, 2007
Last Update Posted Date September 10, 2009
Study Start Date  ICMJE January 2006
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2009)
endoscopy for evaluating the prevalence of esophago-gastric lesions in patients [ Time Frame: 60 day ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2007)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Patients With Non-cardiac Chest Pain
Official Title  ICMJE Evaluation of Patients With Non-cardiac Chest Pain Using PillCam Eso - a Wireless Imaging Capsule of the Esophagus.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Non-Cardiac Chest Pain
  • Gastroesophageal Reflux Disease
Intervention  ICMJE Procedure: Capsule endoscopy
Patient will undergo a capsule endoscopy for the evaluation of their chest pain.
Study Arms  ICMJE No Intervention: Diagnostic capsule endoscopy
Patient with non-cardiac chest pain will undergo capsule endoscopy
Intervention: Procedure: Capsule endoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2009)
40
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2007)
200
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00476398
Other Study ID Numbers  ICMJE 2005P001321
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Associate Physician, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julia J. Liu, MD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP