Evaluation of Patients With Non-cardiac Chest Pain

Phase 4

Completed

• Conditions: Non-Cardiac Chest Pain; Gastroesophageal Reflux Disease
• Interventions: Procedure: Capsule endoscopy

• Registration Number: NCT00476398
• Lead Sponsor: Brigham and Women's Hospital

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-05-21
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-08
• Last Update Posted: 2009-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic capsule endoscopy	Capsule endoscopy	Patient with non-cardiac chest pain will undergo capsule endoscopy

Primary Outcome Measures

Name	Time	Method
endoscopy for evaluating the prevalence of esophago-gastric lesions in patients	60 day