Clinical Trial: Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?

Brief Summary: Non-cardiac chest pain (NCCP) is a common disorder whose pathophysiology is poorly understood. Some evidence suggests it may be related to sustained esophageal contractions (SECs) of longitudinal smooth muscle. The investigators have previously shown that acid is a trigger for SECs and results in shortening of the esophagus. In this study, the investigators plan to prospectively evaluate esophageal shortening responses to acid in a group of patients with NCCP compared to controls. The investigators will use high resolution esophageal manometry coupled with acid infusion to evaluate shortening. The investigators hypothesize that at least a subset of patients with NCCP will have an exaggerated esophageal shortening response to acid which correlates with symptom production. If our hypothesis proves true, this may lead to a future therapeutic target in the treatment of these patients.

Detailed Summary:
Sponsor: Queen's University

Current Primary Outcome: Mean change in esophageal length with acid [ Time Frame: Length at T= 20 minutes - Baseline (T=0) ]

Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion


Original Primary Outcome: Mean change in esophageal length with acid [ Time Frame: 20 minutes ]

Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion


Current Secondary Outcome:

  • Esophageal length at symptom onset [ Time Frame: 20 minutes ]
    Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms
  • Esophageal length at maximal symptom intensity [ Time Frame: 20 minutes ]
    Mean length of esophagus at peak patient reported symptom intensity with acid infusion
  • Correlation between symptom onset and esophageal shortening [ Time Frame: 20 minutes ]
    Esophageal shortening will be defined as the point during the 20 minute acid infusion at which the lower esophageal sphincter begins to migrate proximally. A 2 minute window following this time point will then be used to determine if patients symptoms increased by > 2 on a visual analogue pain scale between 0 - 10.


Original Secondary Outcome: Same as current

Information By: Queen's University

Dates:
Date Received: April 16, 2013
Date Started: October 2013
Date Completion: October 2014
Last Updated: May 20, 2014
Last Verified: May 2014