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Biomarkers in Cardiology (BIC) -3: POstinterventional Elevations of Troponin by Choline (POET-Studie)

Biomarkers in Cardiology (BIC) -3: POstinterventional Elevations of Troponin by Choline (POET-Studie) - POET / BIC-3

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00000278
Enrollment
150
Registered
2010-12-14
Start date
2007-07-12
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I20-I25

Interventions

Group 1: Patients will have 5 blood draws (15 ml each) during the course of the trial: 1. at admission to the hospital 2. after the arterial sheath has been placed in the cath lab (before the procedu

Sponsors

Charité Universitätsmedizin Berlin Campus Virchow Klinikum Med. Klinik m.S. Kardiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Hospitalization for planned percutanous coronary intervention (PCI) Negative Troponin T level at admission

Exclusion criteria

Exclusion criteria: Anemia < 10g/dl Life expactancy < 6 months State of shock or other acute illness Detention by law Withdrawal of patient`s consent Acute vascular occlusion under PCI

Design outcomes

Primary

MeasureTime frame
Post-interventionell Troponin increase. Assessment 8 and 16 hours after PCI. Analyses is performed at the Charité central laboratory.

Secondary

MeasureTime frame
Total length of hospital stay - Assessment from hospital documentation || Severity of coronary artery disease - Analysis of coronary angiography report || Raised of Choline before PCI (at admission). For whole blood choline whole blood samples remain at room temperature for 30 minutes after withdrawal and are then frozen at -20°C, within a maximum of 14 days at -80°C. For plasma choline plasma is stored on ice immediately after withdrawal and is processed within a maximum time of 2 hours until freezing. All samples are analyzed en bloc after the whole trial data set has been completed. Whole blood and plasma choline concentrations were measured on a multi modal microplate reader (Berthold Mithras LB940) based on fast-chemiluminescent technology. This essay is evaluated against the gold standard of mass spectrometry. The lower detection range is 1.4umol/l for plasma choline and 8.8umol/l for whole blood choline. The upper detection ranges are taken from cut-offs published in literature for measurements in acute coronary syndromes (28.2umol/l for WBCHO and 18.5umol/l for plasma choline) and via controll data from the 95th and 99th percentile of a healthy reference population (300 workers at Charité hospital). || Raised level of Myeloperoxidase before PCI (at admission). Processing of blood samples within 2 hours, storage after centrifugation and aliquotation at -80°C. MPO concentrations were determined using the ARCHITECT® instrument (Abbott Park, IL). The assay is a two-step monoclonal antibody sandwich immunoassay using chemiluminescent technology. The ARCHITECT MPO assay demonstrated a total precision ranging from 3.3 to 9.8% when measuring samples with concentrations between 177.1 and 7729.8 pmol/L. The lower limit of detection has been determined to be 10.9 pmol/L. The upper reference limit (URL) was determined with a population of 300 apparently healthy hospital employees with no history of coronary artery disease (CAD), prior MI, heart failure or other card

Countries

Germany

Contacts

Public ContactJulia Searle

Charité Berlin Medizinische Klinik m.S. Kardiologie

julia.searle@charite.de0049 (0)30 450 553307

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026