Distribution of Highly Sensitive Troponin in the Critically Unwell & Associated Mortality

Myocardial Infarction Clinical Trial

— DIGNITY  

Official title:

Distribution of Highly Sensitive Troponin in the Critically Unwell & Associated Mortality. The DIGNITY Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03630237
• Other study ID #: RHM CAR0557
• Status: Recruiting
• Start date: January 28, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: July 2019
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: Jonathan Hinton
• Phone: 0044 (0)2380777222
• Email: jonathan.hinton[@]uhs.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients aged less than 18 years

• No biochemistry samples taken within the ICU stay

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Injury

Locations

Country	Name	City	State
United Kingdom	Univeristy Hospital Southampton	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between high sensitivity troponin and inpatient mortality on all patients admitted to each of the ICU environments at a large teaching hospital		During intensive care admission
Secondary	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	During intensive care admission
Secondary	Association between high sensitivity troponin results and duration of ventilation		Within twenty eight days
Secondary	Association between high sensitivity troponin results and length of intensive care admission		Number of days not in intensive care within twenty eight days of original intensive care admission
Secondary	Association between high sensitivity troponin results and requirement for inotropic support		During intensive care admission