Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by East and North Hertfordshire NHS Trust
Sponsor:
Information provided by (Responsible Party):
Prof Diana Gorog, East and North Hertfordshire NHS Trust
ClinicalTrials.gov Identifier:
NCT02073396
First received: February 25, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Coronary Artery Disease
Other: This is an observational study.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis

Resource links provided by NLM:


Further study details as provided by East and North Hertfordshire NHS Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 140
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)
Groups/Cohorts Assigned Interventions
atrial fibrillation, coronary atrtery disease

Patients diagnosed with coronary disease (n=70) or atrial fibrillation (n=70)

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.
Other: This is an observational study.
as above
Other Names:
  • 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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients diagnosed with coronary disease (n=70) or atrial fibrillation (n=70)Participants will be recruited from amongst in-patients or out-patients

Criteria

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02073396

Contacts
Contact: Maria M Niespialowska-Steuden, MD, MRCP +44 (0)1707224909 mniespialowska@nhs.net
Contact: Diana A Gorog, Prof, MD, PhD +44(0)1707 365 540 d.gorog@imperial.ac.uk

Locations
United Kingdom
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    deepti.sebastian@nhs.net   
Principal Investigator: Diana A Gorog, Prof, MD, PhD         
Sub-Investigator: Maria M Niespialowska-Steuden, Medical Doctor, MRCP         
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
Welwyn Garden City, Herts, United Kingdom, AL7 4HQ
Contact: Fiona Smith, manager    01438 28 6688    Fiona.Smith@whht.nhs.uk]   
Contact: Deepti Sebastian, manager    01438 28 6688 / 01438 28 4461    deepti.sebastian@nhs.net   
Principal Investigator: Diana A Gorog, Prof,MD, PhD         
Sub-Investigator: Maria M Niespialowska-Steuden, MRCP, Medical Doctor         
Sponsors and Collaborators
East and North Hertfordshire NHS Trust
Investigators
Principal Investigator: Diana A Gorog, Prof, MD, PhD East & North Herts NHS Trust
  More Information

No publications provided

Responsible Party: Prof Diana Gorog, MD, PhD, FRCP, East and North Hertfordshire NHS Trust
ClinicalTrials.gov Identifier: NCT02073396     History of Changes
Other Study ID Numbers: No 1.1; 4 Dec 2012, REC 12/EE/0466
Study First Received: February 25, 2014
Last Updated: February 25, 2014
Health Authority: United Kingdom: Research Ethics Committee, 12/EE/0466

Additional relevant MeSH terms:
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis

ClinicalTrials.gov processed this record on July 20, 2014