Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis

NCT02073396 | Completed DMC

• 2 other identifiers: No 1.1; 4 Dec 2012REC 12/EE/0466
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• The occlusion and lysis time.

  The occlusion and lysis timet.

  1-3 months

Secondary Outcomes (1)

• no secondary outcome measures to be identified

  no secondary outcome measures to be identified

Other Outcomes (1)

• no other outcome measures to be identified

  no other outcome measures to be identified

Study Arms (1)

Patients

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

Diagnostic Test: Blood test

Interventions

Blood test DIAGNOSTIC_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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Male and female participants aged 18 years or over.

You may not qualify if:

• Not actively using tobacco products (due to vasoactive and pro-aggregatory effects of nicotine).
• The participant is willing and able to understand the Subject Information Sheet and provide informed consent.
• The participant must agree to comply with the drawing of blood samples for the assessments.
• Male and female participants aged \< 18 years of age.
• Patients with impaired renal function eGFR \<30 ml/min (since renal failure is associated with platelet function defect that may confound results).
• 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.
• The participant has a gives a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease.
• 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.
• Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study.
• 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)
• Currently enrolled in an investigational device or drug trial.

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Artery Disease

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Diana A Gorog, Prof

  East & North Herts NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FRCP

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: January 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

GB (1)