An observational study in Troponin, Age and Mortality, sponsored by Imperial College London. Active, not recruiting. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Imperial College London · Observational
The National Institute for Health Research (NIHR) Cardiovascular Health Informatics Collaborative is an observational, multi-centre and longitudinal study of clinical data from collaborating hospitals. A dataset of the longitudinal record for patients who presented with a suspected acute coronary syndrome, characterised by the request of a troponin test, has been developed (NHIC-Troponin Study).
The NHIC Cardiovascular Project in the United Kingdom was established to enable the sharing and repurposing of routinely captured clinical data for re-use in research. Data sharing for this study has been enabled by establishing a data sharing agreement between each of the collaborating hospitals. The data sharing agreement allows data to be shared between National Health Service (NHS) hospitals in accordance with an anonymisation and de-identification profile approved by each information governance department, ensuring that patient identities are protected. Ethics approval for each dataset has been obtained which detailed the further de-identification steps to ensure that research datasets are fully anonymised.
The cardiovascular theme clinical leads developed a standard target data model specification to capture the longitudinal record for patients who presented with a suspected acute coronary syndrome, characterised by the request of a troponin test (NHIC-Troponin Study). The data model was patient centric allowing for minor discrepancies between dataset areas such as missing discharges or test results returning outside of episodes of care. The model included 156 data points, grouped into demographics, cardiovascular risk factors, emergency department attendance and inpatient episodes, biochemistry, revascularisation and mortality. All patients were followed up on the NHS Spine Application, Summary Care Record until death or censoring on 1st April 2017.
This dataset comprised all patients who had a troponin measured at each of the five major academic centres between 2010 (2008 for University College Hospital) and 2017. The investigators identified a total of 257948 patient records who underwent troponin testing during the study period.
A Committee of Experts validates the protocol methodology and supervises the data management. A Steering Committee oversees study proposals including hypotheses, study design and statistical analyses including planned outcome measures.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 257,948 is above the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients with electronic records at collaborating hospitals.
Exclusion Criteria:
Patients who presented to hospital during the study period (2010-17) and had at least one troponin blood test measured.
Mortality, All-cause
Number of patients who died (from any cause) including in-hospital, short-term and long-term mortality
Time frame: Hospital admission to 3 years follow-up
Acute Revascularisation
Acute revascularisation will be defined as having PCI or CABG in the time window between 48 hours before and 3 months after the first troponin measurement. This will account for patients who had revascularisation, in particular PCI, as an emergency prior to their first troponin blood test and to capture revascularisation, in particular CABG, performed as an outpatient following their index admission.
Time frame: 3 months follow-up
| Milestone | Unselected Cohort of Patients Who Had a Troponin Measured |
|---|---|
| Started | 257948 |
| Completed | 257948 |
| Not completed | 0 |
Number of patients who died (from any cause) including in-hospital, short-term and long-term mortality
| Participants | Unselected Cohort of Patients Who Had a Troponin Measured |
|---|---|
| Mortality, All-cause | 55850 |
Acute revascularisation will be defined as having PCI or CABG in the time window between 48 hours before and 3 months after the first troponin measurement. This will account for patients who had revascularisation, in particular PCI, as an emergency prior to their first troponin blood test and to capture revascularisation, in particular CABG, performed as an outpatient following their index admission.
| Participants | Unselected Cohort of Patients Who Had a Troponin Measured |
|---|---|
| Acute Revascularisation | 17444 |
Collected over Last refresh for troponin dataset was April 2017, reflecting 7 years of follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unselected Cohort of Patients Who Had a Troponin Measured | 55,850/257,948 (21.7%) | — | — |
| Age, Continuous(years) | Unselected Cohort of Patients Who Had a Troponin Measured |
|---|---|
| Median | 65 (50 to 79) |
| Sex: Female, Male(Participants) | Unselected Cohort of Patients Who Had a Troponin Measured |
|---|---|
| Female | 115230 |
| Male | 142718 |
| Race/Ethnicity, Customized(Participants) | Unselected Cohort of Patients Who Had a Troponin Measured |
|---|---|
| White | 147321 |
| South Asian | 7169 |
| Black | 19925 |
| Other | 23401 |
| Missing | 60132 |
| Region of Enrollment(participants) | Unselected Cohort of Patients Who Had a Troponin Measured |
|---|---|
| United Kingdom | 257948 |
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual electronic patient record data for all primary and secondary outcome measures will be made available.
Supporting information: Study protocol, Sap, Csr, Analytic code
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Imperial College London