Comparison of Fingerstick Versus Venous Sample for Troponin I.

NCT04153006 | Completed DMC

• 2 other identifiers: Study number 478NL70186.096.19
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, observational, cohort study aiming to compare point-of-care high-sensitive troponin I testing from different sample types with central laboratory (CL) HS cTnI plasma samples. A registry of all included patients and their troponin results (POC, CL and HS cTnT) will be made to compare these testing methods.

Conditions

Chest Pain; Myocardial Infarction; Myocardial Ischemia; Heart Attack

Keywords

Troponin; Point-of-care; Minicare

Outcome Measures

Primary Outcomes (1)

• Method and sample comparison

  The primary objective is to compare the analytical performance (method and sample comparison) of Minicare® high sensitive troponin I testing (POC, different sample types) and conventional venipuncture troponin I test in our central hospital laboratory (CL) with the Abbott Architect. This comparison will comprise: * Minicare® POC (different sample types) vs conventional HS cTnI CL test (Method comparison) * Minicare® capillary vs. Minicare® venipuncture and vs. Minicare® plasma (Sample comparison) The analyses linked to the primary objectives are: * The agreement between POC (three sample types) and CL testing by using the Bland-Altman method. * The agreement between different POC sample types by using the Bland-Altman method. The primary objective will be achieved by taking capillary and (an extra) venous blood samples (one per timepoint) from every patient presenting at the cardiac ED with chest pain suspected for ACS.

  30 days

Secondary Outcomes (6)

• Major adverse cardiac event (MACE)

  30 days

• Final patients diagnoses.

  30 days

• Overview baseline characteristics.

  30 days

• Linear regression and Pearson's correlation.

  30 days

• Fals-positive and fals-negatives.

  30 days

Study Arms (1)

Chest pain patients

Patients who are admitted to the cardiac ED because of chest pain for ruling out acute coronary syndrome by troponin analysis are eligible for participation. Troponin analysis will be performed according to standard protocol (0-1h protocol). From every included patient capillary blood samples and an extra venous blood sample will be drawn to evaluate HS cTnI levels obtained with the POC instrument and central laboratory (CL).

Device: POC troponin analysis.

Interventions

POC troponin analysis. DEVICE

Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Minicare® device.

Chest pain patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients presented at our cardiology ED are eligible for inclusion if they are 18 years or older and suspected of having an ACS based on history, examination, and ECG.

You may qualify if:

• Patients 18 years or older with chest pain suspected of ACS.

You may not qualify if:

• ST elevation myocardial infarction and out of hospital cardiac arrest.
• Patients with sudden onset tachycardia and a frequency of 110 bpm or higher (supraventricular or ventricular)
• Patients who are hemodynamically unstable or in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.
• Patients recently already admitted for the same set of symptoms at a previous healthcare institution before being transferred to the participating clinical site.
• Patients not willing or not able to provide informed consent due to their medical condition as judged by the physician.

Sponsors & Collaborators

• VieCuri Medical Centre: lead
• Siemens Healthcare Diagnostics Inc: collaborator
• Minicare® B.V.: collaborator

Study Sites (1)

Viecuri MC

Venlo, Limburg, 5912 BL, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and plasma

MeSH Terms

Conditions

Chest Pain; Myocardial Infarction; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Braim Rahel, Dr.

  Viecuri MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator/Cardiologist

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 6, 2019
• Study Start: September 3, 2019
• Primary Completion: March 13, 2020
• Study Completion: April 13, 2020
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

NL (1)