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

Chest Pain Atypical Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839058
• Other study ID #: DMED-1559-13
• Status: Completed
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: November 2018
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Chest Pain Atypical Syndrome

Intervention

Other:
• Esophageal Manometry
Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Esophageal Length With Acid	Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion	Length at T= 20 minutes - Baseline (T=0)
Secondary	Esophageal Length at Symptom Onset	Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms	20 minutes
Secondary	Esophageal Length at Maximal Symptom Intensity	Mean length of esophagus at peak patient reported symptom intensity with acid infusion	20 minutes
Secondary	Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening	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.	20 minutes