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

C

Central Hospital, Nancy, France

Status

Unknown

Conditions

Ischemic Cardiomyopathy

Treatments

Procedure: coronarography and angioplasty

Study type

Observational

Funder types

Other

Identifiers

NCT04897997
20210502VandoeuvreFranceEurope

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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)

Trial design

120 participants in 4 patient groups

non smokers
Description:
never having smoked patients
Treatment:
Procedure: coronarography and angioplasty
smokers
Description:
actively smoking patients
Treatment:
Procedure: coronarography and angioplasty
acute coronary syndrome
Description:
patients with the coronary indication of ACS
Treatment:
Procedure: coronarography and angioplasty
stable
Description:
patients with the coronary indication of stable or silent ischemia
Treatment:
Procedure: coronarography and angioplasty

Trial contacts and locations

1

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Central trial contact

Régis Trimole, MD; Edoardo Camenzind, Professor

Data sourced from clinicaltrials.gov

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