TROPICCAL: TROPonin I in Cardiovascular disease in CriticAL care
Research type
Research Study
Full title
TROPICCAL: TROPonin I in Cardiovascular disease in CriticAL care
IRAS ID
171574
Contact name
Annemarie Docherty
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
We wish to understand the changes that occur over time in the level of Troponin I, a blood test which measures damage to the heart muscle. We are investigating this in people with cardiovascular disease who are admitted to Intensive Care Unit (ICU) or High Dependency Unit (HDU). The recent development of highly sensitive Troponin I blood test has resulted in detectable Troponin levels in many stable patients with cardiovascular disease, and in critically ill patients. We hope that this will validate the use of Troponin I as the endpoint for a future trial looking whether patients with cardiovascular disease benefit from blood transfusion to higher haemoglobin levels when they are anaemic and critically ill.
Population: This study will be based in adult patients who present to ICU or HDU, who have a pre-existing diagnosis of cardiovascular disease.
Intervention: We will use leftover serum from routinely collected blood samples to measure daily Troponin I levels whilst the patient is in ICU/HDU for a maximum of ten days. We will perform daily electrocardiograms(ECG) during the ICU/HDU stay, and we will use some of the information already routinely collected such as blood results and organ failure. Paper and electronic medical records will be reviewed in order to obtain patient follow-up information for up to 6 months following consent to the study. We will anonymise this data
Comparator: This is an exploratory study, in which we are trying to understand the dynamics of Troponin I in critical illness. We will be comparing Troponin I levels both within the patient over the course of his/her critical illness, and between patients with different patterns of disease.
Outcome: we will use ICU, hospital and six month mortality as our primary outcomes. Secondary outcomes will be new ischaemic events: myocardial infarction, and cerebrovascular accident.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
15/NE/0067
Date of REC Opinion
7 Apr 2015
REC opinion
Further Information Favourable Opinion