Clinical trial NCT04897997: Effect of Smoking on Activated Clotting Time Values During Coronarography and Angioplasty
Official title: Effect of Smoking on Activated Clotting Time Values During Coronary Angioplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Cardiomyopathy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: any patient needing a coronarography followed by an angioplasty without the above mentioned exclusion criteria

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.

Eligibility criteria: 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)

Primary outcomes:
measure: ACT values after injection the first injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients
timeFrame: during the intervention
measure: ACT values after injection the second injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients
timeFrame: immediately after the intervention
Secondary outcomes:
measure: ACT values after injection of the first standardized UFH bolus in ex-smokers
timeFrame: during the intervention
measure: ACT values after injection of the second standardized UFH bolus in ex-smokers
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: University Hospital Nancy Brabois
Study officials:
affiliation: University Hospital Nancy France
name: Edoardo Camenzind, Professor
role: STUDY_DIRECTOR
References: