Evaluation of Patients With Non-cardiac Chest Pain

NCT ID: NCT00476398

Last Updated: 2009-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-06-30

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.

Conditions

Non-Cardiac Chest Pain; Gastroesophageal Reflux Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic capsule endoscopy

Patient with non-cardiac chest pain will undergo capsule endoscopy

Group Type: NO_INTERVENTION

Capsule endoscopy

Intervention Type: PROCEDURE

Patient will undergo a capsule endoscopy for the evaluation of their chest pain.

Interventions

Capsule endoscopy

Patient will undergo a capsule endoscopy for the evaluation of their chest pain.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Brigham and Women's Hospital

Principal Investigators

Julia J. Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Other Identifiers

2005P001321

Identifier Type: -

Identifier Source: org_study_id