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

• ClinicalTrials.gov Identifier: NCT01839058
• Recruitment Status: Completed
• First Posted: April 24, 2013
• Results First Posted: August 3, 2017
• Last Update Posted: November 26, 2018
• Sponsor: Queen's University
• Information provided by (Responsible Party): Dr. William Paterson, Queen's University

Study Description

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.

Condition or disease	Intervention/treatment
Chest Pain Atypical Syndrome	Other: Esophageal Manometry

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?
• Study Start Date: October 2013
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Esophageal Length at Symptom Onset [ Time Frame: 20 minutes ]
   Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms
2. Esophageal Length at Maximal Symptom Intensity [ Time Frame: 20 minutes ]
   Mean length of esophagus at peak patient reported symptom intensity with acid infusion
3. Number of Participants for Whom a Correlation Was Found 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

Hotel Dieu Hospital

Kingston, Ontario, Canada, K7L 5G2

Sponsors and Collaborators

Queen's University

Investigators

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

More Information

• Responsible Party: Dr. William Paterson, Professor of Medicine, Queen's University
• ClinicalTrials.gov Identifier: NCT01839058
• Other Study ID Numbers: DMED-1559-13
• First Posted: April 24, 2013
• Results First Posted: August 3, 2017
• Last Update Posted: November 26, 2018
• Last Verified: November 2018

Keywords provided by Dr. William Paterson, Queen's University:

Non Cardiac Chest Pain

Additional relevant MeSH terms:

Chest Pain; Pain; Neurologic Manifestations