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

Ischemic Cardiomyopathy Clinical Trial

Official title:

Effect of Smoking on Activated Clotting Time Values During Coronary Angioplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04897997
• Other study ID #: 20210502VandoeuvreFranceEurope
• Status: Recruiting
• Start date: January 6, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2021
• Source: Central Hospital, Nancy, France
• Contact: Edoardo Camenzind, Professor
• Phone: +33 3 83 15 5339
• Email: edoardo[@]camenzind-cardio.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2022
• Est. primary completion date: August 31, 2022
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemic Cardiomyopathy

Intervention

Procedure:
• coronarography and angioplasty
selective angiography of the coronaries and angioplasty of significant culprit lesion(s)

Locations

Country	Name	City	State
France	University Hospital Nancy Brabois	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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