Troponine-At-Bedside study
| ISRCTN | ISRCTN92275378 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92275378 |
| Secondary identifying numbers | 00-035 |
- Submission date
- 04/08/2007
- Registration date
- 09/08/2007
- Last edited
- 29/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Bertrand Renaud
Scientific
Scientific
GHU Henri Mondor-Albert Chenevier
51, avenue du Maréchal Delattre de Tassigny
Créteil
94010 Cedex
France
Study information
| Study design | Randomized controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | Troponine-At-Bedside study |
| Study acronym | TAB |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | Acute coronary syndrome |
| Intervention | Point-Of-Care testing in the emergency department vs central hospital laboratory testing for troponin I measurement. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/11/2002 |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 800 |
| Total final enrolment | 833 |
| Key inclusion criteria | 1. Age 18 years or older 2. Suspicion of acute coronary syndrom 3. Required to measure troponin I (Ti) |
| Key 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. |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 31/07/2004 |
Locations
Countries of recruitment
- France
Study participating centre
GHU Henri Mondor-Albert Chenevier
Créteil
94010 Cedex
France
94010 Cedex
France
Sponsor information
Dade Behring (France)
Industry
Industry
Immeuble Le Berkeley
19-29 rue du Capitaine Guynemer
Paris La Défense
92903 Cedex
France
"ROR" |
https://ror.org/04q9w3z30 |
|---|
Funders
Funder type
Hospital/treatment centre
The Henri Mondor Hospital (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/02/2008 | 29/10/2021 | Yes | No |
Editorial Notes
29/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
