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Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis

6. februar 2019 opdateret af: Prof Diana Gorog, East and North Hertfordshire NHS Trust
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

140

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Herts
      • Stevenage, Herts, Det Forenede Kongerige, SG1 4AB
        • 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients
Patients diagnosed with coronary disease or atrial fibrillation. All the patients will undergo Global Thrombosis Test.
Diagnostisk test: Blood 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The occlusion and lysis time.
Tidsramme: 1-3 months
The occlusion and lysis timet.
1-3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
no secondary outcome measures to be identified
Tidsramme: no secondary outcome measures to be identified
no secondary outcome measures to be identified
no secondary outcome measures to be identified

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
no other outcome measures to be identified
Tidsramme: no other outcome measures to be identified
no other outcome measures to be identified
no other outcome measures to be identified

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

East and North Hertfordshire NHS Trust

Efterforskere

  • Ledende efterforsker: Diana A Gorog, Prof, East & North Herts NHS Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2013

Primær færdiggørelse (Faktiske)

1. september 2018

Studieafslutning (Faktiske)

1. september 2018

Datoer for studieregistrering

Først indsendt

25. februar 2014

Først indsendt, der opfyldte QC-kriterier

25. februar 2014

Først opslået (Skøn)

27. februar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • No 1.1; 4 Dec 2012
  • REC 12/EE/0466 (Anden identifikator: NRES Committee East of England - Essex, UK)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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