- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01724996
Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups
May 26, 2014 updated by: University of Zurich
To determine the significance of a simple bedside clinical test (chest wall tenderness) to exclude myocardial ischemia in different demographic groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
When a patient is presenting with acute chest pain at the ER of the University Hospital of Zurich, the study physician in charge, who is acting simultaneously as one of four attending clinical physicians, is performing the physical examination according to routine clinical practice.
The physical examination includes the testing of chest wall tenderness: Palpation of chest wall tenderness in lying 30° elevation of chest position.
Flat index with standardized pressure where spontaneous maximum pain is reported (reproducible vs. not reproducible pain vs. no pain).
Negative control (right side of chest mid-clavicle intercostal 6/7), reproducible vs. not reproducible pain vs. no pain.
The same physician, who is blinded for the final diagnosis at the time of the physical examination, is also recording the patient history including the study interview using the standardized study questionnaire.
Study Type
Observational
Enrollment (Actual)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Division of Internal Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patiens seaking the Emergency room of the University Hospital Zurich because of chest pain
Description
Inclusion criteria: All patients over the age of 18 years presenting with the leading symptom of first time or recurrent acute chest pain in the emergency room of the Department of Internal Medicine, University Hospital of Zurich.
Exclusion criteria:
- Missing informed consent.
- Cardiopulmonary unstable patients.
- No self reported chest pain.
- Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia, cardiogenic shock.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chest wall tenderness
Time Frame: From first presententation to omission (6-12 hours)
|
Chest wall tenderness in patients presenting with acute chest pain and acute coronary syndrome (ACS) (ST-elevation myocardial infarction, STEMI/Non-ST-elevation myocardial infarction, NSTEMI /unstable angina pectoris) vs. chest wall tenderness in patients presenting with chest pain and without ACS in different demographic groups (Age under vs. over 50 years; male vs. female, with vs. without CVRF).
|
From first presententation to omission (6-12 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain description
Time Frame: 6-12 hours
|
Localization/Radiation of pain/first time/recurrent/ Patient thinks heart is the cause/ different CVRF/Illicit drugs/Medication - in combination with "reproducible/not reproducible pain" associated with ACS
|
6-12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
November 5, 2012
First Submitted That Met QC Criteria
November 7, 2012
First Posted (Estimate)
November 12, 2012
Study Record Updates
Last Update Posted (Estimate)
May 28, 2014
Last Update Submitted That Met QC Criteria
May 26, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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