Effect of Smoking on Activated Clotting Time Values During Coronarography and Angioplasty

Study Overview
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Brief Summary
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analyzing influence of smoking on patients anti-coagulation status as assessed by ACT measurements during coronary angioplasty

Detailed Description
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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.

Official Title
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Effect of Smoking on Activated Clotting Time Values During Coronary Angioplasty

Conditions
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Ischemic Cardiomyopathy

Intervention / Treatment
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* Procedure: coronarography and angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: any patient older than 18 years needing a diagnostic coronarography was eligible for enrollment Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non smokers<br>never having smoked patients | Procedure: coronarography and angioplasty<br>* selective angiography of the coronaries and angioplasty of significant culprit lesion(s)<br>|
| smokers<br>actively smoking patients | Procedure: coronarography and angioplasty<br>* selective angiography of the coronaries and angioplasty of significant culprit lesion(s)<br>|
| acute coronary syndrome<br>patients with the coronary indication of ACS | Procedure: coronarography and angioplasty<br>* selective angiography of the coronaries and angioplasty of significant culprit lesion(s)<br>|
| stable<br>patients with the coronary indication of stable or silent ischemia | Procedure: coronarography and angioplasty<br>* selective angiography of the coronaries and angioplasty of significant culprit lesion(s)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACT values after injection the first injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients | 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) | during the intervention | 
| ACT values after injection the second injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients | 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) | immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACT values after injection of the first standardized UFH bolus in ex-smokers | ACT values after injection of the first standardized UFH bolus in ex-smokers requiring a coronarography followed by a PTCA | during the intervention | 
| ACT values after injection of the second standardized UFH bolus in ex-smokers | ACT values after injection of the second standardized UFH bolus in ex-smokers requiring a coronarography followed by a PTCA | immediately after the intervention |