Related Experiment Video
Updated: Jan 27, 2026

In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
Long-term biological variation of high-sensitivity cardiac troponin T using minimal important differences and
Tobias Täger1, Evangelos Giannitsis1, Kjeld Greve1
1Zentrum für Innere Medizin, Klinik für Kardiologie, Angiologie und Pneumologie, Universitätsklinikum Heidelberg, Germany.
Insights
Biological variation of high-sensitivity cardiac troponin T (hs-cTnT) in stable cardiovascular disease patients over 12 months depends on baseline levels. Minimal important difference (MID) shows low biovariability, aiding clinical interpretation of hs-cTnT changes.
Area of Science:
- Cardiology
- Clinical Chemistry
- Biomarker Analysis
Background:
- Cardiovascular disease (CVD) management relies on monitoring biomarkers like high-sensitivity cardiac troponin T (hs-cTnT).
- Understanding the long-term biological variation of hs-cTnT is crucial for accurate interpretation in stable outpatients.
Purpose of the Study:
- To evaluate the long-term biological variation of hs-cTnT in stable outpatients with CVD.
- To determine reference change values (RCVs) and minimal important differences (MIDs) for hs-cTnT over a 12-month interval.
Main Methods:
- hs-cTnT was measured at baseline and 12 months in 169 stable CVD outpatients.
- Exclusion criteria were applied to 965 patients to ensure cohort stability.
- Biological variation was assessed using RCVs and MIDs, analyzed across subgroups (sex, age, renal function).
Main Results:
- The 12-month minimal important difference (MID) was 3.8 ng/L (44.2%), and the reference change value (RCV) was 5.1 ng/L (28.1%).
- MID and RCV were dependent on baseline hs-cTnT concentrations, converging between 11-25 ng/L.
- Similar patterns were observed across subgroups, indicating consistent biological variation.
Conclusions:
- Long-term biological variation of hs-cTnT in stable CVD outpatients is influenced by baseline concentration.
- Minimal important difference (MID) demonstrates low biovariability over 12 months, supporting its clinical utility.
- Findings are consistent across key subgroups, enhancing the reliability of hs-cTnT interpretation.
Objective:
To evaluate the long term biological variation of high-sensitivity cardiac troponin T (hs-cTnT) in stable outpatients with cardiovascular disease (CVD).
Methods:
After applying 8 exclusion criteria to 965 patients, hs-cTnT was measured at index visit and at a 12-month interval in 169 stable outpatients presenting for routine follow-up visits for any CVD. Stability was defined as absence of any endpoint within the follow-up period. Reference change values (RCVs) and minimal important differences (MIDs) were determined to assess biological variation of hs-cTnT.
Results:
MID and RCV for the 12 months interval in patients were 3.8 ng/L or 44.2%, respectively. MID and transformed MID values were lower than the corresponding RCV with a value of 5.1 ng/L for the transformed RCV and 28.1% for the transformed MID. Similar patterns were shown in different subgroups as sex, age, and renal function. We observed a baseline hs-cTnT value dependent change of MID and RCV with increasing values for MID and decreasing values for RCV which converge to stable values between a baseline hs-cTNT value of 11 to 25 ng/L.
Conclusions:
Biological variation of hs-cTnT over 12 months in stable outpatients depends on the concentration at index visit, and is consistent among important prespecified subgroups. MID shows a low biovariability over 12 months. Clinical Trials Identifier:NCT01954303.
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