Overview

This trial is active, not recruiting.

Condition chest pain atypical syndrome
Treatment esophageal manometry
Sponsor Queen's University
Start date October 2013
End date October 2014
Trial size 30 participants
Trial identifier NCT01839058, DMED-1559-13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.
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 volunteers without esophageal symptoms are to undergo esophageal manometry testing.
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.

Primary Outcomes

Measure
Mean change in esophageal length with acid
time frame: Length at T= 20 minutes - Baseline (T=0)

Secondary Outcomes

Measure
Esophageal length at symptom onset
time frame: 20 minutes
Esophageal length at maximal symptom intensity
time frame: 20 minutes
Correlation between symptom onset and esophageal shortening
time frame: 20 minutes

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?
Principal investigator William Paterson, MD, FRCPC
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Queen's University.