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Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis

Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02073396
Enrollment
140
Registered
2014-02-27
Start date
2013-01-31
Completion date
2018-09-30
Last updated
2019-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Coronary Artery Disease

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTBlood test

Patients will undergo the tests of thrombosis, before and after stabilisation of their cardiac condition. Cardiac stabilisation will be provided by clinical cardiac teams, outside and independently from the study.

Sponsors

East and North Hertfordshire NHS Trust
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male and female participants aged 18 years or over. 2. Patients diagnosed with CAD or AF and free of

Exclusion criteria

below. 3. Not actively using tobacco products (due to vasoactive and pro-aggregatory effects of nicotine). 4. The participant is willing and able to understand the Subject Information Sheet and provide informed consent. 5. The participant must agree to comply with the drawing of blood samples for the assessments.

Design outcomes

Primary

MeasureTime frameDescription
The occlusion and lysis time.1-3 monthsThe occlusion and lysis timet.

Secondary

MeasureTime frameDescription
no secondary outcome measures to be identifiedno secondary outcome measures to be identifiedno secondary outcome measures to be identified

Other

MeasureTime frameDescription
no other outcome measures to be identifiedno other outcome measures to be identifiedno other outcome measures to be identified

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026