TroponinNHIC-CVNCT03507309
NIHR CV Health Informatics Collaborative
An observational study of Troponin and Age, run by Imperial College London.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- How many people
- 257,948 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to 31 Mar 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with electronic records at collaborating hospitals.
Who may be able to join
- All patients presenting to one of the collaborating hospitals.
Who cannot join
- Nil
About this study
Official title: National Institute for Health Research (NIHR) Cardiovascular Health Informatics Collaborative
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).
Read the detailed description
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.
- Conditions
- Troponin, Age, Mortality, Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unselected cohort of patients who had a troponin measured | Patients who presented to hospital during the study period (2010-17) and had at least one troponin blood test measured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality, All-cause
Number of patients who died (from any cause) including in-hospital, short-term and long-term mortality
Measured: Hospital admission to 3 years follow-up
Secondary outcomes (1)
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.
Measured: 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study startJan 2016
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TroponinStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257,948 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Trust, Oxford University Hospitals NHS Trust, University College London Hospitals, University Hospital Southampton NHS Foundation Trust, University Hospitals, Leicester, University Hospitals Bristol and Weston NHS Foundation Trust, Manchester University NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Blackpool Teaching Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Jamil Mayet, Imperial College London
- Investigators
- Jamil Mayet, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507309
- Sponsor's protocol ID
- 174052
- Other IDs
- 16/HRA/3327
- Acronym
- NHIC-CV
- Status last verified
- Jul 2024
- First submitted
- 23 Feb 2018
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual electronic patient record data for all primary and secondary outcome measures will be made available.
Publications
Collard D, Chen Y, Kaura A, Mulla A, Glampson B, Davies J, Papadimitriou D, Woods K, O'Gallagher K, Mayer E, Lee R, Herbert C, Grant SW, Curzen N, Squire I, Johnson T, Shah AM, Perera D, Kharbanda RK, Channon K, Williams B, Hemingway H, Hingorani AD, Asselbergs FW, Mayet J, Shah AD, Patel RS. Improving the diagnostic performance of troponin assays for acute myocardial infarction in renal impairment. Heart. 2026 Jun 9:heartjnl-2025-327658. doi: 10.1136/heartjnl-2025-327658. Online ahead of print.
PubMed 42264918Scott JK, Johnson T, Caskey FJ, Bailey P, Selman LE, Mulla A, Glampson B, Davies J, Papdimitriou D, Woods K, O'Gallagher K, Williams B, Asselbergs FW, Mayer EK, Lee R, Herbert C, Grant SW, Curzen N, Squire I, Kharbanda R, Shah A, Perera D, Patel RS, Channon K, Mayet J, Kaura A, Ben-Shlomo Y. Association between kidney function, frailty and receipt of invasive management after acute coronary syndrome. Open Heart. 2024 Oct 9;11(2):e002875. doi: 10.1136/openhrt-2024-002875.
PubMed 39384342Kaura A, Hartley A, Panoulas V, Glampson B, Shah ASV, Davies J, Mulla A, Woods K, Omigie J, Shah AD, Thursz MR, Elliott P, Hemmingway H, Williams B, Asselbergs FW, O'Sullivan M, Lord GM, Trickey A, Sterne JA, Haskard DO, Melikian N, Francis DP, Koenig W, Shah AM, Kharbanda R, Perera D, Patel RS, Channon KM, Mayet J, Khamis R. Mortality risk prediction of high-sensitivity C-reactive protein in suspected acute coronary syndrome: A cohort study. PLoS Med. 2022 Feb 22;19(2):e1003911. doi: 10.1371/journal.pmed.1003911. eCollection 2022 Feb.
PubMed 35192610Kaura A, Panoulas V, Glampson B, Davies J, Mulla A, Woods K, Omigie J, Shah AD, Channon KM, Weber JN, Thursz MR, Elliott P, Hemingway H, Williams B, Asselbergs FW, O'Sullivan M, Kharbanda R, Lord GM, Melikian N, Patel RS, Perera D, Shah AM, Francis DP, Mayet J. Association of troponin level and age with mortality in 250 000 patients: cohort study across five UK acute care centres. BMJ. 2019 Nov 20;367:l6055. doi: 10.1136/bmj.l6055.
PubMed 31748235
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Institute for Health Research (NIHR) Cardiovascular Health Informatics Collaborative
- ClinicalTrials.gov ID
- NCT03507309
- Acronym / sponsor ID
- NHIC-CV / 174052
- Conditions
- Troponin, Age, Mortality, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 257,948 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Trust, Oxford University Hospitals NHS Trust, University College London Hospitals, University Hospital Southampton NHS Foundation Trust, University Hospitals, Leicester, University Hospitals Bristol and Weston NHS Foundation Trust, Manchester University NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Blackpool Teaching Hospitals NHS Foundation Trust
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 25 Apr 2018 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unselected cohort of patients who had a troponin measured | – | –Patients who presented to hospital during the study period (2010-17) and had at least one troponin blood test measured. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with electronic records at collaborating hospitals.
Key inclusion criteria (1 listed)
- All patients presenting to one of the collaborating hospitals.
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality, All-cause
Time frame: Hospital admission to 3 years follow-up
Number of patients who died (from any cause) including in-hospital, short-term and long-term mortality
1 secondary outcome
Acute Revascularisation
Time frame: 3 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42264918Collard D, Chen Y, Kaura A, Mulla A, Glampson B, Davies J, Papadimitriou D, Woods K, O'Gallagher K, Mayer E, Lee R, Herbert C, Grant SW, Curzen N, Squire I, Johnson T, Shah AM, Perera D, Kharbanda RK, Channon K, Williams B, Hemingway H, Hingorani AD, Asselbergs FW, Mayet J, Shah AD, Patel RS. Improving the diagnostic performance of troponin assays for acute myocardial infarction in renal impairment. Heart. 2026 Jun 9:heartjnl-2025-327658. doi: 10.1136/heartjnl-2025-327658. Online ahead of print.
- Derived from this study: PubMed 39384342Scott JK, Johnson T, Caskey FJ, Bailey P, Selman LE, Mulla A, Glampson B, Davies J, Papdimitriou D, Woods K, O'Gallagher K, Williams B, Asselbergs FW, Mayer EK, Lee R, Herbert C, Grant SW, Curzen N, Squire I, Kharbanda R, Shah A, Perera D, Patel RS, Channon K, Mayet J, Kaura A, Ben-Shlomo Y. Association between kidney function, frailty and receipt of invasive management after acute coronary syndrome. Open Heart. 2024 Oct 9;11(2):e002875. doi: 10.1136/openhrt-2024-002875.
- Derived from this study: PubMed 35192610Kaura A, Hartley A, Panoulas V, Glampson B, Shah ASV, Davies J, Mulla A, Woods K, Omigie J, Shah AD, Thursz MR, Elliott P, Hemmingway H, Williams B, Asselbergs FW, O'Sullivan M, Lord GM, Trickey A, Sterne JA, Haskard DO, Melikian N, Francis DP, Koenig W, Shah AM, Kharbanda R, Perera D, Patel RS, Channon KM, Mayet J, Khamis R. Mortality risk prediction of high-sensitivity C-reactive protein in suspected acute coronary syndrome: A cohort study. PLoS Med. 2022 Feb 22;19(2):e1003911. doi: 10.1371/journal.pmed.1003911. eCollection 2022 Feb.
- Derived from this study: PubMed 31748235Kaura A, Panoulas V, Glampson B, Davies J, Mulla A, Woods K, Omigie J, Shah AD, Channon KM, Weber JN, Thursz MR, Elliott P, Hemingway H, Williams B, Asselbergs FW, O'Sullivan M, Kharbanda R, Lord GM, Melikian N, Patel RS, Perera D, Shah AM, Francis DP, Mayet J. Association of troponin level and age with mortality in 250 000 patients: cohort study across five UK acute care centres. BMJ. 2019 Nov 20;367:l6055. doi: 10.1136/bmj.l6055.
- Creating 'big data' from health records to improve careLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual electronic patient record data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamil Mayet principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
An observational study of Troponin and Age, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality, All-cause (time frame: Hospital admission to 3 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03507309, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.