Condition category
Circulatory System
Date applied
04/08/2007
Date assigned
09/08/2007
Last edited
09/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bertrand Renaud

ORCID ID

Contact details

GHU Henri Mondor-Albert Chenevier
51
avenue du Maréchal Delattre de Tassigny
Créteil
94010 Cedex
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

00-035

Study information

Scientific title

Acronym

TAB

Study hypothesis

We hypothesized that Point of Care Testing in the emergency department for troponin I measurement would be associated with a faster process of care, including for patients presenting with non specific symptoms.

Ethics approval

The Institutional Review Board for the Protection of Human Subjects of Henri Mondor Hospital approved the study protocol and patient informed consent procedures in June 2002.

Study design

Randomized controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Acute coronary syndrome

Intervention

Point-Of-Care testing in the emergency department vs central hospital laboratory testing for troponin I measurement.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Time to anti-ischemic therapy.

Secondary outcome measures

1. Time to physician notification of troponin I level
2. Length of stay within the emergency department defined by the time to bed assignment
3. Mortality at 30 and 90 days after presentation
4. Level of emergency department staff reliability on Point-Of-Care testing versus central hospital laboratory testing as assessed by the proportion of second troponin I tests ordered after the Point-Of-Care testing

Overall trial start date

01/11/2002

Overall trial end date

31/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years or older
2. Suspicion of acute coronary syndrom
3. Required to measure troponin I (Ti)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Patients presenting with ST-elevation Acute Coronary Syndrome (ACS) (typical chest pain and persistent [>20 min] ST-segment elevation [>0.1 mV in limb leads or 0.2 mV in precordial leads]) did not represent such a diagnostic challenge compared to NSTE-ACS and were candidate for urgent reperfusion procedure, and therefore were excluded from the current analysis.

Other exclusion criteria:
2. Refusal or inability to provide informed consent
3. Previous enrolment in the study

Additionally, aiming to select patients with high risk ACS, the patients who had 1-2 Ti levels consistently <0.10 µg/L within eight hours of the onset of ACS symptoms were excluded from the study post-hoc.

Recruitment start date

01/11/2002

Recruitment end date

31/07/2004

Locations

Countries of recruitment

France

Trial participating centre

GHU Henri Mondor-Albert Chenevier
Créteil
94010 Cedex
France

Sponsor information

Organisation

Dade Behring (France)

Sponsor details

Immeuble Le Berkeley
19-29 rue du Capitaine Guynemer
Paris La Défense
92903 Cedex
France

Sponsor type

Industry

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The Henri Mondor Hospital (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes