Role of Esophageal Mast Cell Activation in Noncardiac Chest Pain (NCCP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Penn State University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00219492
First received: September 16, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Chest pain is a common clinical complaint. About 30% patients with chest pain will have a normal coronary angiogram and are described as having noncardiac chest pain (NCCP). It is estimated that 25% of the population complain of chest pain at some time in their lifetime. The pathogenesis of NCCP is unknown. Esophageal hypersensitivity as a result of inflammation is considered to be an important mechanism in the development of this pain sensation. Little is currently known about the interaction between inflammatory mediators and peripheral afferent nerve terminals in the esophagus. The mast cell is one of the most enriched pro-inflammatory cells in the gastrointestinal tract. Activation of the mucosal mast cell releases a variety of mediators into adjacent tissues. We hypothesize that mediators released by mast cells sensitize esophageal nociceptors and induce pain sensation.


Condition
Noncardiac Chest Pain (NCCP)

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Role of Esophageal Mast Cell Activation in Noncardiac Chest Pain (NCCP)

Resource links provided by NLM:


Further study details as provided by Penn State University:

Estimated Enrollment: 90
Study Start Date: September 2005
Estimated Study Completion Date: September 2008
Detailed Description:
  1. Key Objectives: To determine the density and activation of esophageal mast cells in non-cardiac chest pain patients. We expect to find mast cell activation, as measured by mast cell count or degranluation, tryptase staining, and histamine release, will be greater in NCCP patients compared to controls, and the increased mast cell activation will correlate with the severity of NCCP. These results will expand our understanding of the pathogenesis of esophageal originated NCCP, and allow the development of new diagnostic and treatment options.
  2. Study Population: (i) NCCP (ii) Reflux esophagitis (iii) Control subjects.
  3. Summary of Procedures: (i) symptom assessment by chest pain questionnaire; (ii) esophageal reflux evaluation by review of records of 24-hour pH monitoring; (iii) evidence of esophagitis by endoscopy; (iv) esophageal biopsy by endoscopy; (v) mast cell activation study in biopsy specimen by mast cell count, tryptase and Transient receptor potential vanniloid-1 (TRPV1) staining, and histamine release assay.
  4. Major Risks & Discomforts: There are no major risks & discomforts other than involved in standard upper GI endoscopy.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • NCCP – presence of a history of chest pain with a negative cardiac evaluation, no evidence of gross esophagitis on endoscopy, and lack of any exclusion criteria; Reflux esophagitis – presence of chest pain or heartburn, negative cardiac evaluation, lack of exclusion criteria and presence of esophagitis on endoscopy;
  • Controls – lack of history of chest pain, lack of exclusion criteria and lack of esophagitis on endoscopy. It is anticipated that patients being evaluated for heme positive stool or GI bleeding would be included as controls.

Exclusion Criteria:

- History of ischemic heart disease, history of asthma, significant food allergies, celiac disease, chronic inflammatory conditions (SLE, rheumatoid arthritis), atopic skin disease, varices, coagulopathy, recent drug treatment with steroids.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00219492

Contacts
Contact: Shaouyong Yu, MD, MPH 717-531-4466 suy13@psu.edu
Contact: Ann Ouyang, MD 717-531-8741 aouyang@psu.edu

Locations
United States, Pennsylvania
Penn State College of Medicine Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Kathyrn Kaylor    717-531-4466    kkaylor@psu.edu   
Principal Investigator: Shaoyong Yu, MD, MPH         
Sub-Investigator: Ann Ouyang, MD         
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Shaoyong Yu, MD, MPH Department of Medicine, Penn State College of Medicine Hershey Medical Center
Study Director: Ann Ouyang, MD Penn State College of Medicine Hershey Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00219492     History of Changes
Other Study ID Numbers: 21370
Study First Received: September 16, 2005
Last Updated: September 16, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
NCCP, mast cell, esophagus

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014