Myocardial InfarctionDIGNITYNCT03630237
Distribution of Highly Sensitive Troponin in the Critically Unwell & Associated Mortality
An observational study of Myocardial Infarction and Myocardial Injury, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The current diagnostic criteria for a heart attack require evaluation of a patient's symptoms and ECG but importantly a blood test called troponin. With advancing technology this test has become more sensitive and is now called a high sensitivity troponin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Myocardial Injury
- How many people
- 1,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jan 2019to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients admitted any of the three adult intensive care units at a large teaching hospital that have at least one biochemistry sample performed as part of their routine care
Who may be able to join
- Adult patients (aged 18 years or older) admitted to any of the three intensive care facilities on site (general, cardiac and neurosciences)
- Biochemistry samples already taken as part of routine clinical care during the ICU stay
Who cannot join
- Patients aged less than 18 years
- No biochemistry samples taken within the ICU stay
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Univeristy Hospital Southampton
Southampton, SO16 6YD
Jonathan Hinton, jonathan.hinton@uhs.nhs.uk
Zoe Nicholas, zoe.nicholas@uhs.nhs.uk
About this study
Official title: Distribution of Highly Sensitive Troponin in the Critically Unwell & Associated Mortality. The DIGNITY Study
The current diagnostic criteria for a heart attack require evaluation of a patient's symptoms and ECG but importantly a blood test called troponin. With advancing technology this test has become more sensitive and is now called a high sensitivity troponin. This is a very effective way of rapidly excluding a heart attack if the test is negative. However there are a number of causes of a raised high sensitivity other than a heart attack, particularly critical illness states. In the absence of features of a heart attack an abnormal result therefore suggests that the heart is inflamed or unwell causing the release of high sensitivity troponin. The DIGNITY study will examine the consequences of high sensitivity troponin elevation in patients in intensive care and assess whether it has a role as a biomarker for predicting outcome.
- Conditions
- Myocardial Infarction, Myocardial Injury
- Medical subject headings
- Myocardial Infarction
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 |
|---|---|---|
| Intensive care population | All patients admitted to any of the three adult intensive care units (general, cardiac \& neurosciences) at a large teaching hospital. These patients will have a high sensitivity troponin added onto biochemistry samples requested by the clinical team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between high sensitivity troponin and inpatient mortality on all patients admitted to each of the ICU environments at a large teaching hospital
Measured: During intensive care admission
Secondary outcomes (4)
Distribution of high sensitivity troponin results for different admissions to intensive care
Distribution of high sensitivity troponin results in
- Medical admissions
- Trauma / emergency surgical admissions
- Planned surgical admissions
- Post cardiac surgical patients
- Neurosurgical patients
Measured: During intensive care admission
Association between high sensitivity troponin results and duration of ventilation
Measured: Within twenty eight days
Association between high sensitivity troponin results and length of intensive care admission
Measured: Number of days not in intensive care within twenty eight days of original intensive care admission
Association between high sensitivity troponin results and requirement for inotropic support
Measured: During intensive care admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start28 Jan 2019
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Curzen, BM, PhD, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630237
- Sponsor's protocol ID
- RHM CAR0557
- Acronym
- DIGNITY
- Status last verified
- Jul 2019
- First submitted
- 9 Aug 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Highly Sensitive Troponin in the Critically Unwell & Associated Mortality. The DIGNITY Study
- ClinicalTrials.gov ID
- NCT03630237
- Acronym / sponsor ID
- DIGNITY / RHM CAR0557
- Conditions
- Myocardial Infarction, Myocardial Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current diagnostic criteria for a heart attack require evaluation of a patient's symptoms and ECG but importantly a blood test called troponin. With advancing technology this test has become more sensitive and is now called a high sensitivity troponin. This is a very effective way of rapidly excluding a heart attack if the test is negative. However there are a number of causes of a raised high sensitivity other than a heart attack, particularly critical illness states. In the absence of features of a heart attack an abnormal result therefore suggests that the heart is inflamed or unwell causing the release of high sensitivity troponin. The DIGNITY study will examine the consequences of high sensitivity troponin elevation in patients in intensive care and assess whether it has a role as a biomarker for predicting outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive care population | – | –All patients admitted to any of the three adult intensive care units (general, cardiac \& neurosciences) at a large teaching hospital. These patients will have a high sensitivity troponin added onto biochemistry samples requested by the clinical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients admitted any of the three adult intensive care units at a large teaching hospital that have at least one biochemistry sample performed as part of their routine care
Key inclusion criteria (2 listed)
- Adult patients (aged 18 years or older) admitted to any of the three intensive care facilities on site (general, cardiac and neurosciences)
- Biochemistry samples already taken as part of routine clinical care during the ICU stay
Key exclusion criteria (2 listed)
- Patients aged less than 18 years
- No biochemistry samples taken within the ICU stay
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
Association between high sensitivity troponin and inpatient mortality on all patients admitted to each of the ICU environments at a large teaching hospital
Time frame: During intensive care admission
4 secondary outcomes
Distribution of high sensitivity troponin results for different admissions to intensive care
Time frame: During intensive care admission
Association between high sensitivity troponin results and duration of ventilation
Time frame: Within twenty eight days
Association between high sensitivity troponin results and length of intensive care admission
Time frame: Number of days not in intensive care within twenty eight days of original intensive care admission
Association between high sensitivity troponin results and requirement for inotropic support
Time frame: During intensive care admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Nick Curzen, BM, PhD principal investigator
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Myocardial Injury, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Hinton (0044 (0)2380777222 ext. 3912, jonathan.hinton@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between high sensitivity troponin and inpatient mortality on all patients admitted to each of the ICU environments at a large teaching hospital (time frame: During intensive care admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2019.