NCT01724996

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

1.1 years

First QC Date

November 5, 2012

Last Update Submit

May 26, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Pain description

    6-12 hours

Interventions

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.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patiens seaking the Emergency room of the University Hospital Zurich because of chest pain

You may not qualify if:

  • Missing informed consent.
  • Cardiopulmonary unstable patients.
  • No self reported chest pain.
  • Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia, cardiogenic shock.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Internal Medicine

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Grani C, Senn O, Bischof M, Cippa 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.

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Franzen, MD

    University Hospital Zurich, Division of Internal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 12, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2013

Study Completion

April 1, 2014

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations