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

Effect of Smoking on Activated Clotting Time Values During Coronary Angioplasty

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04897997
Enrollment
120
Registered
2021-05-24
Start date
2020-01-06
Completion date
2022-09-30
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Cardiomyopathy

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.

Interventions

PROCEDUREcoronarography and angioplasty

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

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

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)

Design outcomes

Primary

MeasureTime frameDescription
ACT values after injection the first injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patientsduring the interventioncomparison of ACT values after injection of two standardized UFH boluses between non-smoking and actively smoking patients (non-smoker group versus active smoker group)
ACT values after injection the second injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patientsimmediately after the interventioncomparison of ACT values after injection of two standardized UFH boluses between non-smoking and actively smoking patients (non-smoker group versus active smoker group)

Secondary

MeasureTime frameDescription
ACT values after injection of the first standardized UFH bolus in ex-smokersduring the interventionACT values after injection of the first standardized UFH bolus in ex-smokers requiring a coronarography followed by a PTCA
ACT values after injection of the second standardized UFH bolus in ex-smokersimmediately after the interventionACT values after injection of the second standardized UFH bolus in ex-smokers requiring a coronarography followed by a PTCA

Countries

France

Contacts

Primary ContactEdoardo Camenzind, Professor
edoardo@camenzind-cardio.net+33 3 83 15 5339
Backup ContactRégis Trimole, MD
trimole.regis@gmail.com+33 6 02 37 4187

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026