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

NCT ID: NCT04897997

Last Updated: 2021-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-06

Study Completion Date

2022-09-30

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.

Conditions

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Ischemic Cardiomyopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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non smokers

never having smoked patients

coronarography and angioplasty

Intervention Type PROCEDURE

selective angiography of the coronaries and angioplasty of significant culprit lesion(s)

smokers

actively smoking patients

coronarography and angioplasty

Intervention Type PROCEDURE

selective angiography of the coronaries and angioplasty of significant culprit lesion(s)

acute coronary syndrome

patients with the coronary indication of ACS

coronarography and angioplasty

Intervention Type PROCEDURE

selective angiography of the coronaries and angioplasty of significant culprit lesion(s)

stable

patients with the coronary indication of stable or silent ischemia

coronarography and angioplasty

Intervention Type PROCEDURE

selective angiography of the coronaries and angioplasty of significant culprit lesion(s)

Interventions

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coronarography and angioplasty

selective angiography of the coronaries and angioplasty of significant culprit lesion(s)

Intervention Type PROCEDURE

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Pr Camenzind

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edoardo Camenzind, Professor

Role: STUDY_DIRECTOR

University Hospital Nancy France

Locations

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University Hospital Nancy Brabois

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Edoardo Camenzind, Professor

Role: CONTACT

+33 3 83 15 5339

Régis Trimole, MD

Role: CONTACT

+33 6 02 37 4187

Facility Contacts

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Sophie Adam

Role: primary

+33 3 83 15 3296

Other Identifiers

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20210502VandoeuvreFranceEurope

Identifier Type: -

Identifier Source: org_study_id

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