Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis
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|ClinicalTrials.gov Identifier: NCT02073396|
Recruitment Status : Recruiting
First Posted : February 27, 2014
Last Update Posted : August 3, 2016
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Coronary Artery Disease||Other: Global Thrombosis Test|
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.
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Observational Model:||Case Control|
|Official Title:||Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
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).
- The occlusion and lysis time as measured by Global Thrombosis Test. [ Time Frame: 1-3 months ]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 ]no secondary outcome measures to be identified
- no other outcome measures to be identified [ Time Frame: no other outcome measures to be identified ]no other outcome measures to be identified
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073396
|Contact: Maria M Niespialowska-Steuden, Dr||+44 (0)email@example.com|
|Contact: Diana A Gorog, Prof||+44(0)1707 365 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Diana A Gorog, Prof|
|Sub-Investigator: Maria M Niespialowska-Steuden, MRCP|
|Principal Investigator:||Diana A Gorog, Prof||East & North Herts NHS Trust|