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

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.

Study Overview

• Status: Completed
• Conditions: Chest Pain Atypical Syndrome
• Intervention / Treatment: Other: Esophageal Manometry

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 5G2
      • Hotel Dieu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with non cardiac chest pain as diagnosed by cardiologist or other physician. Healthy Volunteers will include anyone in the Kingston area who fulfils Inclusion and Exclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esophageal Length at Symptom Onset	Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms	20 minutes
Esophageal Length at Maximal Symptom Intensity	Mean length of esophagus at peak patient reported symptom intensity with acid infusion	20 minutes
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

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: William Paterson, MD, FRCPC, Queen's University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 16, 2013
• First Submitted That Met QC Criteria: April 19, 2013
• First Posted (Estimate): April 24, 2013

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 23, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Non Cardiac Chest Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• Other Study ID Numbers: DMED-1559-13