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Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01724996
First Posted: November 12, 2012
Last Update Posted: May 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose
To determine the significance of a simple bedside clinical test (chest wall tenderness) to exclude myocardial ischemia in different demographic groups.

Condition Intervention Phase
Chest Pain Other: Clinical examination: chest wall tenderness Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Enrollment: 110
Study Start Date: October 2012
Study Completion Date: April 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Clinical examination: chest wall tenderness
    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.
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.
  Eligibility

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patiens seaking the Emergency room of the University Hospital Zurich because of chest pain
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724996


Locations
Switzerland
University Hospital Zurich, Division of Internal Medicine
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Daniel Franzen, MD University Hospital Zurich, Division of Internal Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01724996     History of Changes
Other Study ID Numbers: CP1
First Submitted: November 5, 2012
First Posted: November 12, 2012
Last Update Posted: May 28, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Acute Coronary Syndrome
Chest Pain
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms