Atrial FibrillationNCT02073396
Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis
An observational study of Atrial Fibrillation and Coronary Artery Disease, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Coronary Artery Disease
- What is being tested?
- Blood test
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with coronary disease or atrial fibrillation. Participants will be recruited from amongst in-patients or out-patients
Who may be able to join
- Male and female participants aged 18 years or over.
- Patients diagnosed with CAD or AF and free of exclusion criteria below.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 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
About this study
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.
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Being tested
- Blood test
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients diagnosed with coronary disease or atrial fibrillation. All the patients will undergo Global Thrombosis Test. Receives: Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occlusion and lysis time.
The occlusion and lysis timet.
Measured: 1-3 months
Secondary outcomes (1)
no secondary outcome measures to be identified
no secondary outcome measures to be identified
Measured: no secondary outcome measures to be identified
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startJan 2013
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof Diana Gorog, East and North Hertfordshire NHS Trust
- Investigators
- Diana A Gorog, Prof, Principal investigator, East & North Herts NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073396
- Sponsor's protocol ID
- No 1.1; 4 Dec 2012
- Other IDs
- REC 12/EE/0466
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2014
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis
- ClinicalTrials.gov ID
- NCT02073396
- Acronym / sponsor ID
- No 1.1; 4 Dec 2012
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Study start
- Jan 2013
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Blood testPatients diagnosed with coronary disease or atrial fibrillation. All the patients will undergo Global Thrombosis Test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with coronary disease or atrial fibrillation. Participants will be recruited from amongst in-patients or out-patients
Key inclusion criteria (5 listed)
- Male and female participants aged 18 years or over.
- Patients diagnosed with CAD or AF and free of exclusion criteria below.
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testPatients 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. | Diagnostic test | Patients |
Primary outcome
The occlusion and lysis time.
Time frame: 1-3 months
The occlusion and lysis timet.
1 secondary outcome
no secondary outcome measures to be identified
Time frame: no secondary outcome measures to be identified
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana A Gorog, Prof principal investigator
East & North Herts NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Coronary Artery Disease, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occlusion and lysis time. (time frame: 1-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.