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

Completed

• Conditions: Chest Pain Atypical Syndrome
• Interventions: Other: Esophageal Manometry

• Registration Number: NCT01839058
• Lead Sponsor: Queen's University

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-04-16
• Study First Submitted QC: 2013-04-19
• Study First Posted: 2013-04-24
• Study Start: 2013-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2017-04-25
• Results First Submitted QC: 2017-04-25
• Results First Posted: 2017-08-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-23
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

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

Inclusion Criteria

• Healthy volunteers:
• free of esophageal symptoms
• not on any acid suppressing medications
• Non Cardiac Chest Pain Patients:
• Angina like chest pain occuring at least once per month
• Coronary artery disease ruled out by stress test or angiogram

Exclusion Criteria

• pre existing motility disorder of the esophagus
• connective tissue disease
• pregnancy
• taking calcium channel blockers, Nitrates, Gabapentin, Narcotics, Tricyclic antidepressants, Anti seizure medications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Esophageal Manometry	Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.
Non Cardiac Chest Pain Patients	Esophageal Manometry	Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.

Primary Outcome Measures

Name	Time	Method
Mean Change in Esophageal Length With Acid	Length at T= 20 minutes - Baseline (T=0)	Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion

Secondary Outcome Measures

Name	Time	Method
Esophageal Length at Symptom Onset	20 minutes	Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms
Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening	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.
Esophageal Length at Maximal Symptom Intensity	20 minutes	Mean length of esophagus at peak patient reported symptom intensity with acid infusion

Trial Locations

Locations (1)

Hotel Dieu Hospital; 🇨🇦 Kingston, Ontario, Canada