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CompletedNCT02073396Updated Feb 8, 2019

Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis

An observational study in Atrial Fibrillation and Coronary Artery Disease, sponsored by East and North Hertfordshire NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by East and North Hertfordshire NHS Trust · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
140
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation
  • Coronary Artery Disease
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.

This study's enrollment of 140 is below the median of 300 across 1,362 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

East and North Hertfordshire NHS Trust is the lead sponsor of 36 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients diagnosed with coronary disease or atrial fibrillation. Participants will be recruited from amongst in-patients or out-patients

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.

Exclusion criteria

Exclusion Criteria:

  1. Male and female participants aged \< 18 years of age.
  2. Patients with impaired renal function eGFR \<30 ml/min (since renal failure is associated with platelet function defect that may confound results).
  3. The participant has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, haemorrhagic metabolic or other disease likely to confound the study requirements or analyses.
  4. The participant has a gives a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease.
  5. Alcohol consumption above recommended safe levels (i.e. more than 21 units per week for males, or more than 14 units per week for females) due to the potential effects of high alcohol levels on platelet reactivity.
  6. Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study.
  7. Any major bleeding diathesis or blood dyscrasia (platelets \< 70 x 109/l, Hb \<8 g/dl, INR>1.4, APTT> x 2UNL, leucocyte count\< 3.5x 109/l, neutrophil count \< 1x 109/l)
  8. Currently enrolled in an investigational device or drug trial.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
140 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients

    Patients diagnosed with coronary disease or atrial fibrillation. All the patients will undergo Global Thrombosis Test.

    Diagnostic Test: Blood test

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.

06

What researchers measure

Primary outcomes

  1. The occlusion and lysis time.

    The occlusion and lysis timet.

    Time frame: 1-3 months

Secondary outcomes

  1. no secondary outcome measures to be identified

    no secondary outcome measures to be identified

    Time frame: no secondary outcome measures to be identified

Other outcomes

  1. no other outcome measures to be identified

    no other outcome measures to be identified

    Time frame: no other outcome measures to be identified

07

Study locations

1 site
  • 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
    Stevenage, Herts SG1 4AB, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02073396
Lead sponsor
East and North Hertfordshire NHS Trust
Responsible party
Prof Diana Gorog (MD, PhD, FRCP, East and North Hertfordshire NHS Trust) — Principal investigator
First posted
Feb 27, 2014
Start date
Jan 2013
Primary completion
Sep 2018
Completion
Sep 2018
Last update
Feb 8, 2019

Study contacts

Diana A Gorog, Prof
principal investigator · East & North Herts NHS Trust

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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