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

NCT04897997 | Unknown

• 1 other identifier: 20210502VandoeuvreFranceEurope
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• ACT values after injection of the first standardized UFH bolus in ex-smokers

  during the intervention

• ACT values after injection of the second standardized UFH bolus in ex-smokers

  immediately after the intervention

Study Arms (4)

non smokers

never having smoked patients

Procedure: coronarography and angioplasty

smokers

actively smoking patients

Procedure: coronarography and angioplasty

acute coronary syndrome

patients with the coronary indication of ACS

Procedure: coronarography and angioplasty

stable

patients with the coronary indication of stable or silent ischemia

Procedure: coronarography and angioplasty

Interventions

coronarography and angioplasty PROCEDURE

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

acute coronary syndrome; non smokers; smokers; stable

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• any patient older than 18 years needing a diagnostic coronarography was eligible for enrollment

You may not qualify if:

• 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)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

University Hospital Nancy Brabois

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sampling

MeSH Terms

Interventions

Angioplasty

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Edoardo Camenzind, Professor

  University Hospital Nancy France

  STUDY DIRECTOR

Central Study Contacts

Edoardo Camenzind, Professor

CONTACT

+33 3 83 15 5339; edoardo@camenzind-cardio.net

Régis Trimole, MD

CONTACT

+33 6 02 37 4187; trimole.regis@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 24, 2021
• Study Start: January 6, 2020
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2022
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)