Chest Pain Atypical Syndrome
Conditions
Keywords
Non Cardiac Chest Pain
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.
Interventions
OTHEREsophageal 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.
Sponsors
Queen's University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Esophageal Length With Acid | Length at T= 20 minutes - Baseline (T=0) | Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal Length at Symptom Onset | 20 minutes | Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms |
| Esophageal Length at Maximal Symptom Intensity | 20 minutes | Mean length of esophagus at peak patient reported symptom intensity with acid infusion |
| Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non Cardiac Chest Pain Patients 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. | 17 |
| Healthy Controls 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. | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | Non Cardiac Chest Pain Patients | Healthy Controls | Total |
|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 10.1 | 49.4 years STANDARD_DEVIATION 18.3 | 50.9 years STANDARD_DEVIATION 14.5 |
| Region of Enrollment Canada | 17 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 19 |
| other Total, other adverse events | 0 / 21 | 0 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
Primary
Mean Change in Esophageal Length With Acid
Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion
Time frame: Length at T= 20 minutes - Baseline (T=0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non Cardiac Chest Pain Patients | Mean Change in Esophageal Length With Acid | -0.40 centimeters | Standard Deviation 0.54 |
| Healthy Controls | Mean Change in Esophageal Length With Acid | -0.39 centimeters | Standard Deviation 0.55 |
Secondary
Esophageal Length at Maximal Symptom Intensity
Mean length of esophagus at peak patient reported symptom intensity with acid infusion
Time frame: 20 minutes
Population: Data Not collected given lack of correlation between symptoms and esophageal length.
Secondary
Esophageal Length at Symptom Onset
Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms
Time frame: 20 minutes
Population: As pre-specified in the protocol, this Outcome Measure was intended to be analyzed only if a correlation was found between esophageal shortening and symptom production. Thus data was not collected.
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.
Time frame: 20 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non Cardiac Chest Pain Patients | Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening | 0 Participants |
| Healthy Controls | Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening | 0 Participants |