Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis
Patients with coronary artery disease (CAD) and atrial fibrillation (AF) are at increased risk of stroke and heart attack. Such events are usually caused by increased stickiness of the blood causing a blood clot to block the artery (thrombus) in the heart or the brain. The aim of this study is to assess the stickiness of the blood (global thrombotic status) in patients with CAD and AF at baseline and after clinical stabilisation to see how disease state and clinical treatments affect the stickiness of the blood (thrombotic status). This will be a single centre study. Patients diagnosed with CAD or AF will have a blood sample taken at baseline and after clinical stabilisation. Blood stickiness will be tested with the Global Thrombosis Test. The results will be evaluated to assess the effect of disease process and clinical state on blood stickiness to gain further understanding of this condition and form the basis for future studies aimed at identifying patients who are at high risk of future cardiovascular events, based on increased blood stickiness.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis|
- The occlusion and lysis time as measured by Global Thrombosis Test. [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]The occlusion and lysis time as measured by Global Thrombosis Test.
- no secondary outcome measures to be identified [ Time Frame: no secondary outcome measures to be identified ] [ Designated as safety issue: No ]no secondary outcome measures to be identified
- no other outcome measures to be identified [ Time Frame: no other outcome measures to be identified ] [ Designated as safety issue: No ]no other outcome measures to be identified
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Patients diagnosed with coronary disease or atrial fibrillation. All the patients will undergo Global Thrombosis Test.
Other: Global Thrombosis Test
Patients will undergo the Global Thrombosis Test, before and after stabilisation of their cardiac condition. Cardiac stabilisation will be provided by clinical cardiac teams, outside and independently from the study. The Global Thrombosis Test assesses thrombotic and thrombolytic status, by measuring the time of thrombus (occlusion time, OT), and time needed for lysis of the thrombus (lysis time, LT).
Impaired thrombotic status is associated with adverse cardiovascular events. Patients with coronary artery disease (CAD) and atrial fibrillation (AF) are at increased risk of thrombotic events. It is not known whether thrombotic status differs in these patients, or how thrombotic status alters in response to clinical stabilisation with treatment.
The aim of this study is to assess the global thrombotic status (stickiness of the blood) in patients with coronary artery disease and atrial fibrillation at baseline and after clinical stabilisation.
This is a small, pilot, hypothesis-generating study. Design Single centre, hypothesis-generating study. Patients diagnosed with coronary disease (n=70) or atrial fibrillation (n=70) recruited from amongst in-patients or out-patients, will have a blood draw at presentation and after clinical stabilisation. Blood will be tested to assess global thrombotic status.
The recruitment period is 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02073396
|Contact: Maria M Niespialowska-Steuden, Dr||+44 (0)firstname.lastname@example.org|
|Contact: Diana A Gorog, Prof||+44(0)1707 365 email@example.com|
|East & North Herts NHS Trust (Queen Elizabeth II Hospital, Howlands, Welwyn Garden City, AL7 4HQ and Lister Hospital, Coreys Mill Lane, Stevenage, Herts , SG1 4AB -those two hospitals operate as one institution||Recruiting|
|Stevenage, Herts, United Kingdom, SG1 4AB|
|Contact: Fiona Smith, Manager 01438 28 6688 Fiona.Smith@whht.nhs.uk]|
|Contact: Deepti Sebastian, Manager 01438 28 6688 firstname.lastname@example.org|
|Principal Investigator: Diana A Gorog, Prof|
|Sub-Investigator: Maria M Niespialowska-Steuden, MRCP|
|Principal Investigator:||Diana A Gorog, Prof||East & North Herts NHS Trust|