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

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: NCT00219492
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

Tracking Information
First Submitted Date September 16, 2005
First Posted Date September 22, 2005
Last Update Posted Date June 20, 2017
Study Start Date September 2005
Actual Primary Completion Date August 21, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of Esophageal Mast Cell Activation in Noncardiac Chest Pain (NCCP)
Official Title Role of Esophageal Mast Cell Activation in Noncardiac Chest Pain (NCCP)
Brief Summary 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.
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.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Noncardiac Chest Pain (NCCP)
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Completed
Actual Enrollment
 (submitted: June 16, 2017)
86
Original Enrollment
 (submitted: September 16, 2005)
90
Actual Study Completion Date August 21, 2014
Actual Primary Completion Date August 21, 2014   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00219492
Other Study ID Numbers 21370
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Milton S. Hershey Medical Center
Study Sponsor Milton S. Hershey Medical Center
Collaborators Not Provided
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
PRS Account Milton S. Hershey Medical Center
Verification Date June 2017