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

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724996
• Other study ID #: CP1
• Status: Completed
• Phase: Phase 4
• First received: November 5, 2012
• Last updated: May 26, 2014
• Start date: October 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

To determine the significance of a simple bedside clinical test (chest wall tenderness) to exclude myocardial ischemia in different demographic groups.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Internal Medicine	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest wall tenderness	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)	No
Secondary	Pain description	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	No