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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
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 21, 2007
    Last Updated
    September 8, 2009
    Sponsor
    Brigham and Women's Hospital
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    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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