Li-Hep vs. Non-Li-Hep Coated Transfer Device
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|ClinicalTrials.gov Identifier: NCT04458155|
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment|
|Acute Coronary Syndrome Chest Pain Myocardial Infarction Cardiac Ischemia||Device: Siemens® Point-of-care high sensitibe troponin I analyzer|
In September 2019, the validation study 1.0 started, in which the cTnI result of the Siemens POC device on three sample types are compared. Interim analysis of the sample comparison was performed by regression analysis using Passing and Bablock, and calculating the Pearson correlation coefficient.
The Li-hep Plasma vs Li-hep venous blood show a very good correlation of 1.00-1.03 with an R of >0.99, so the results between these sample types can be used interchangeably. For the capillary sample vs the Li-hep sample (both blood and plasma) the slope is 8-12% higher. With a 8-12% higher response, the capillary test results may not be interchangeably used with the other 2 sample types.
It is remarkable that capillary samples give a higher response, since it was anticipated that the result may be slightly lower due to the possible dilution by interstitial fluid. We hypothesize that the presence of the Li-heparin anti-coagulant in the venous draw lead to a slight reduction of the apparent cTnI concentration. By using a heparin coated transfer device for the capillary samples instead of an uncoated transfer device, this hypothesis will be tested.
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||Sample Comparison With Siemens® Point-of-care Device for Cardiac Troponin I Assay by Using a Heparin Coated Transfer Device vs. Non-heparin Coated Transfer Device at the Emergency Department (Validation Study 2.0)|
|Actual Study Start Date :||June 18, 2020|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
Chest pain patients
Patients are eligble for participation if they are admitted to:
Troponin analysis will be performed according to standard protocol . From every included patient two capillary blood samples and an extra venous blood sample will be drawn during regulary ordered blood work to evaluate HS cTnI levels obtained with the POC instrument.
Device: Siemens® Point-of-care high sensitibe troponin I analyzer
Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Siemens® device.
- Sample comparison [ Time Frame: 30 days ]
The primary objective is to compare the analytical performance of Siemens® point-of-care high sensitive troponin I testing in different sample types by using the coefficient of variation.
This comparison will comprise Siemens® POC capillary vs. Siemens® POC venipuncture and vs. Siemens® POC plasma (Sample comparison).
The primary objective will be achieved by taking:
- Two capillary samples > one sample with a heparin coated transfer device (drawn from a finger of the right hand) and the other one with a non-heparin coated transfer device. (drawn from a finger of the left hand)
- One extra venous blood sample > for POC venous and POC plasma analysis.
Trained clinical staff will collect the different samples. All samples will be collected once, at one time point with a maximum of 10 minutes in between.
- Bland-Altman method [ Time Frame: 30 days ]To compare the analytical performance of Siemens® point-of-care high sensitive troponin I testing in different sample types by using the Bland-Altman method.
- Linear regression and Pearson's correlation. [ Time Frame: 30 days ]The relationship between POC sample types by linear regression and Pearson's correlation.
- Overview baseline characteristics. [ Time Frame: 30 days ]To create an overview of baseline characteristics of the population.
- Major adverse cardiac event (MACE) [ Time Frame: 30 days ]MACE is is defined as a composite of cardiac death and myocardial infarction.
- Modified HEART score [ Time Frame: 30 days ]To determine the modified HEART score retrospectively based upon POC capillary results in the population.
- Modified HEART score comparison [ Time Frame: 30 days ]To compare the retrospectively determined modified HEART score based upon POC capillary heparin coated transfer device with the retrospectively determined modified HEART score based upon POC capillary non-heparin coated transfer device.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458155
|Contact: Lisa Frenk, Drs.||+firstname.lastname@example.org|
|Contact: Anne Bruinen, Dr.||+email@example.com|
|Viecuri Medical Center||Recruiting|
|Venlo, Limburg, Netherlands, 5912 BL|
|Contact: Lisa Frenk, Drs. 077 320 5555 firstname.lastname@example.org|
|Contact: Anne Bruinen, Drs. 077 320 5555 email@example.com|
|Sub-Investigator: Lisa Frenk, Drs.|
|Sub-Investigator: Anne Bruinen, Dr.|
|Principal Investigator: Braim Rahel, Dr.|
|Principal Investigator:||Braim Rahel, Dr.||VieCuri Medical Centre|