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

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ClinicalTrials.gov Identifier: NCT01724996
Recruitment Status : Completed
First Posted : November 12, 2012
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date November 5, 2012
First Posted Date November 12, 2012
Last Update Posted Date May 28, 2014
Study Start Date October 2012
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2012)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01724996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 7, 2012)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups
Official Title Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups
Brief Summary To determine the significance of a simple bedside clinical test (chest wall tenderness) to exclude myocardial ischemia in different demographic groups.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patiens seaking the Emergency room of the University Hospital Zurich because of chest pain
Condition Chest Pain
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Gräni C, Senn O, Bischof M, Cippà PE, Hauffe T, Zimmerli L, Battegay E, Franzen D. Diagnostic performance of reproducible chest wall tenderness to rule out acute coronary syndrome in acute chest pain: a prospective diagnostic study. BMJ Open. 2015 Jan 28;5(1):e007442. doi: 10.1136/bmjopen-2014-007442.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 26, 2014)
110
Original Estimated Enrollment
 (submitted: November 7, 2012)
320
Actual Study Completion Date April 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01724996
Other Study ID Numbers CP1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators Not Provided
Investigators
Principal Investigator: Daniel Franzen, MD University Hospital Zurich, Division of Internal Medicine
PRS Account University of Zurich
Verification Date May 2014