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

NCT01839058 | Completed Results

• 1 other identifier: DMED-1559-13
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain Atypical Syndrome

Keywords

Non Cardiac Chest Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Esophageal Length at Symptom Onset

  20 minutes

• Esophageal Length at Maximal Symptom Intensity

  20 minutes

• Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening

  20 minutes

Study Arms (2)

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

Healthy Controls

Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.

Other: Esophageal Manometry

Interventions

Esophageal Manometry OTHER

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; Non Cardiac Chest Pain Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

Results Point of Contact

• Title: Keith McIntosh
• Organization: Western University

keith.mcintosh@sjhc.london.on.ca

519-646-6100

Study Officials

• William Paterson, MD, FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 24, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 26, 2018
• Results First Posted: August 3, 2017

Record last verified: 2018-11

Locations

CA (1)