Effect of Smoking on Activated Clotting Time Values During Coronarography and Angioplasty
- Conditions
- Ischemic Cardiomyopathy
- Interventions
- Procedure: coronarography and angioplasty
- Registration Number
- NCT04897997
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
analyzing influence of smoking on patients anti-coagulation status as assessed by ACT measurements during coronary angioplasty
- Detailed Description
During angioplasty, activated clotting time (ACT) measurements are recommended to attest the correct anticoagulation level and if anticoagulation levels are suboptimal after the two first boluses, additional unfractionated heparin (UFH) injections are recommended until obtention of a therapeutic ACT values (250-350s).
The study hypothesis was that the procoagulant effect of the tobacco may be responsible of reduced anticoagulation levels after standardized UFH administrations and thus presenting an UFH resistance requiring increased UFH dosages to obtain a therapeutic ACT values.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- any patient older than 18 years needing a diagnostic coronarography was eligible for enrollment
- unconscious patient
- any patient presenting with one of the following characteristic known to impact either on ACT or aPTT measurements as: oral anticoagulation medication (anti-vitamin K and non-vitamin K antagonist oral anticoagulants [NOAC]), fondaparinux or LMWH usage, coagulopathy defined as prothrombin time < 50 % or thrombopenia < 50 000 G/L, declared or observed thrombophilia defined as antithrombin < 50%, baseline aPTT values with a ratio patient/control > 1.2 presence of lupus anticoagulant, connective tissue disease, active cancer
- a person as defined by the law articles L. 1121-5, L. 1121-7 et L1121-8 of the Code de la santé publique, France (pregnant, parturient women or breastfeeding women, legally adult patient under legal protection measure [tutelage, protection of vulnerable adults]),
- a person as defined by the law articles L. 3212-1 et L. 3213-1 of the Code de la santé publique, France (legally adult patient unable to consent, person with legal or administrative freedom restriction or person under psychiatric treatment)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description acute coronary syndrome coronarography and angioplasty patients with the coronary indication of ACS stable coronarography and angioplasty patients with the coronary indication of stable or silent ischemia non smokers coronarography and angioplasty never having smoked patients smokers coronarography and angioplasty actively smoking patients
- Primary Outcome Measures
Name Time Method ACT values after injection the second injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients immediately after the intervention comparison of ACT values after injection of two standardized UFH boluses between non-smoking and actively smoking patients (non-smoker group versus active smoker group)
ACT values after injection the first injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients during the intervention comparison of ACT values after injection of two standardized UFH boluses between non-smoking and actively smoking patients (non-smoker group versus active smoker group)
- Secondary Outcome Measures
Name Time Method ACT values after injection of the second standardized UFH bolus in ex-smokers immediately after the intervention ACT values after injection of the second standardized UFH bolus in ex-smokers requiring a coronarography followed by a PTCA
ACT values after injection of the first standardized UFH bolus in ex-smokers during the intervention ACT values after injection of the first standardized UFH bolus in ex-smokers requiring a coronarography followed by a PTCA
Trial Locations
- Locations (1)
University Hospital Nancy Brabois
🇫🇷Vandœuvre-lès-Nancy, France