Chest Pain Atypical SyndromeNCT01839058
Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?
An observational study of Chest Pain Atypical Syndrome, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chest Pain Atypical Syndrome
- What is being tested?
- Esophageal Manometry
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Oct 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- pre existing motility disorder of the esophagus
- connective tissue disease
- pregnancy
- taking calcium channel blockers, Nitrates, Gabapentin, Narcotics, Tricyclic antidepressants, Anti seizure medications
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Esophageal Manometry
- Keywords
- Non Cardiac Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal ManometryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Non Cardiac Chest Pain Patients | Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing. Receives: Other: Esophageal Manometry | |
| Healthy Controls | Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing. Receives: Other: Esophageal Manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Esophageal Length With Acid
Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion
Measured: Length at T= 20 minutes - Baseline (T=0)
Secondary outcomes (3)
Esophageal Length at Symptom Onset
Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms
Measured: 20 minutes
Esophageal Length at Maximal Symptom Intensity
Mean length of esophagus at peak patient reported symptom intensity with acid infusion
Measured: 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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chest Pain Atypical SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. William Paterson, Queen's University
- Investigators
- William Paterson, MD, FRCPC, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839058
- Sponsor's protocol ID
- DMED-1559-13
- Status last verified
- Nov 2018
- First submitted
- 16 Apr 2013
- Last updated
- 26 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?
- ClinicalTrials.gov ID
- NCT01839058
- Acronym / sponsor ID
- DMED-1559-13
- Conditions
- Chest Pain Atypical Syndrome
- Keywords
- Non Cardiac Chest Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Posted 3 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Cardiac Chest Pain Patients | – | Other: Esophageal ManometryPatients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing. |
| Healthy Controls | – | Other: Esophageal ManometryHealthy volunteers without esophageal symptoms are to undergo esophageal manometry testing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- pre existing motility disorder of the esophagus
- connective tissue disease
- pregnancy
- taking calcium channel blockers, Nitrates, Gabapentin, Narcotics, Tricyclic antidepressants, Anti seizure medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal ManometryBoth 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. | Other | Healthy Controls, Non Cardiac Chest Pain Patients |
Primary outcome
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
3 secondary outcomes
Esophageal Length at Symptom Onset
Time frame: 20 minutes
Esophageal Length at Maximal Symptom Intensity
Time frame: 20 minutes
Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening
Time frame: 20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chest Pain Atypical Syndrome
Not yet recruiting
The Use of Artificial Intelligence-Enhanced Electrocardiograms in the Chest Pain Clinic to Risk Stratify Patients, Provide Rapid Reassurance and Enable a Low-Cost Clinical Pathway
Angina (Stable), Chest Pain Atypical Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Paterson, MD, FRCPC principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain Atypical Syndrome, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Esophageal Length With Acid (time frame: Length at T= 20 minutes - Baseline (T=0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.