Ischemic CardiomyopathyNCT04897997
Effect of Smoking on Activated Clotting Time Values During Coronarography and Angioplasty
An observational study of Ischemic Cardiomyopathy, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
analyzing influence of smoking on patients anti-coagulation status as assessed by ACT measurements during coronary angioplasty Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Cardiomyopathy
- What is being tested?
- coronarography and angioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2020to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: any patient needing a coronarography followed by an angioplasty without the above mentioned exclusion criteria
Who may be able to join
- any patient older than 18 years needing a diagnostic coronarography was eligible for enrollment
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Nancy Brabois
Vandœuvre-lès-Nancy, 54500
Sophie Adam, +33 3 83 15 3296, s.adam@chru-nancy.fr
About this study
Official title: 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
Read the 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.
- Conditions
- Ischemic Cardiomyopathy
- Being tested
- coronarography and angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronarography and angioplastyProcedure or surgery
selective angiography of the coronaries and angioplasty of significant culprit lesion(s)
| Study group | Role | What they receive |
|---|---|---|
| non smokers | never having smoked patients Receives: Procedure: coronarography and angioplasty | |
| smokers | actively smoking patients Receives: Procedure: coronarography and angioplasty | |
| acute coronary syndrome | patients with the coronary indication of ACS Receives: Procedure: coronarography and angioplasty | |
| stable | patients with the coronary indication of stable or silent ischemia Receives: Procedure: coronarography and angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: immediately after the intervention
Secondary outcomes (2)
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
Measured: 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
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start6 Jan 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Camenzind, Central Hospital, Nancy, France
- Investigators
- Edoardo Camenzind, Professor, Study director, University Hospital Nancy France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897997
- Sponsor's protocol ID
- 20210502VandoeuvreFranceEurope
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking on Activated Clotting Time Values During Coronary Angioplasty
- ClinicalTrials.gov ID
- NCT04897997
- Acronym / sponsor ID
- 20210502VandoeuvreFranceEurope
- Conditions
- Ischemic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| non smokers | – | Procedure: coronarography and angioplastynever having smoked patients |
| smokers | – | Procedure: coronarography and angioplastyactively smoking patients |
| acute coronary syndrome | – | Procedure: coronarography and angioplastypatients with the coronary indication of ACS |
| stable | – | Procedure: coronarography and angioplastypatients with the coronary indication of stable or silent ischemia |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- any patient needing a coronarography followed by an angioplasty without the above mentioned exclusion criteria
Key inclusion criteria (1 listed)
- any patient older than 18 years needing a diagnostic coronarography was eligible for enrollment
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronarography and angioplastyselective angiography of the coronaries and angioplasty of significant culprit lesion(s) | Procedure or surgery | acute coronary syndrome, non smokers, smokers, stable |
Primary outcome
ACT values after injection the first injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients
Time frame: during the intervention
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)
ACT values after injection the second injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients
Time frame: immediately after the intervention
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)
2 secondary outcomes
ACT values after injection of the first standardized UFH bolus in ex-smokers
Time frame: during the intervention
ACT values after injection of the second standardized UFH bolus in ex-smokers
Time frame: immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edoardo Camenzind, Professor study director
University Hospital Nancy France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Cardiomyopathy, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edoardo Camenzind, Professor (+33 3 83 15 5339, edoardo@camenzind-cardio.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACT values after injection the first injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients (time frame: during the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.