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

Effect of Smoking on Activated Clotting Time Values During Coronary Angioplasty

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

Study Overview

• Status: Recruiting
• Conditions: Ischemic Cardiomyopathy
• Intervention / Treatment: Procedure: coronarography and 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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Edoardo Camenzind, Professor; Phone Number: +33 3 83 15 5339; Email: edoardo@camenzind-cardio.net
• Study Contact Backup: Name: Régis Trimole, MD; Phone Number: +33 6 02 37 4187; Email: trimole.regis@gmail.com

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54500
    • Recruiting
    • University Hospital Nancy Brabois
    • Contact: Sophie Adam; Phone Number: +33 3 83 15 3296; Email: s.adam@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

any patient needing a coronarography followed by an angioplasty without the above mentioned exclusion criteria

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non smokers; never having smoked patients	Procedure: coronarography and angioplasty; selective angiography of the coronaries and angioplasty of significant culprit lesion(s)
smokers; actively smoking patients	Procedure: coronarography and angioplasty; selective angiography of the coronaries and angioplasty of significant culprit lesion(s)
acute coronary syndrome; patients with the coronary indication of ACS	Procedure: coronarography and angioplasty; selective angiography of the coronaries and angioplasty of significant culprit lesion(s)
stable; patients with the coronary indication of stable or silent ischemia	Procedure: coronarography and angioplasty; selective angiography of the coronaries and angioplasty of significant culprit lesion(s)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Director: Edoardo Camenzind, Professor, University Hospital Nancy France

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: 20210502VandoeuvreFranceEurope

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No