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Addiction in Intensive Cardiac Care Units (ADDICT-CCU)

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ClinicalTrials.gov Identifier: NCT05063097
Recruitment Status : Recruiting
First Posted : September 30, 2021
Last Update Posted : September 30, 2021
Sponsor:
Collaborator:
Fondation Coeur et Recherche
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date July 19, 2021
First Posted Date September 30, 2021
Last Update Posted Date September 30, 2021
Actual Study Start Date April 6, 2021
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 22, 2021)
Prevalence of psychoactive drug use assessed by urine drug assay at the time of patient admission. [ Time Frame: Day 0 ]
The following psychoactive drugs will be evaluated for all consecutive patients by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) within two hours of admission to the CCU: i) cannabinoids (tetrahydrocannabinol [THC]), including cannabis and hashish; ii) cocaine and metabolites, including cocaine and crack; iii) amphetamines; iv) MDMA; and v) heroin and other opioids. In addition to the analysis of psychoactive drug use, the investigators will also use the NarcoCheck® urine drug assay to evaluate the associated use of the following psychostimulant drugs: barbiturates, benzodiazepines, tricyclic antidepressant drugs, methadone and buprenorphine.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 22, 2021)
  • In-hospital major adverse events (MAE) [ Time Frame: Up to 3 months ]
    In-hospital major adverse events (MAE) will be a combined outcome including:
    • all-cause mortality,
    • cardiogenic shock according to the European Society of Cardiology (ESC) guidelines, and requiring medical (catecholamines or inotropic agents) or mechanical haemodynamic support
    • cardiac arrest: severe ventricular arrhytmia requiring defibrillation or anti-arrhytmic agents
    This outcome will be assessed by the clinical team in charge of the CCU during the hospitalization.
  • Duration of the hospitalization [ Time Frame: Up to 3 months ]
    The duration of the hospitalization of each patient in CCU and in the hospital.
  • Combined major adverse clinical events (MACE). [ Time Frame: 6 months of follow-up ]
    MACE will be defined as all-cause death or unplanned hospitalization for acute cardiovascular reasons, confirmed by independent adjudication experts who will review medical documents according to the standardized definitions.
  • All cause mortality [ Time Frame: 6 months of follow-up ]
    The adjudication of all-cause death was performed using the electronic French National Registry of Death (Institut National de la Statistique et des Etudes Economiques, INSEE registry).
  • The occurrence of cardiovascular events [ Time Frame: 6 months of follow-up ]
    Other secondary outcomes will be assessed by independent adjudication experts will be as follows: all-cause death, cardiovascular mortality, nonfatal myocardial infarction, unstable angina, resuscitated cardiac arrest, hospitalizations for heart failure, heart transplantation or implantation of a mechanical circulatory support device, sustained ventricular arrhythmias, coronary revascularization, stroke, venous thromboembolic events, endocarditis and the implantation of a pacemaker or implantable cardioverter-defibrillator.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Addiction in Intensive Cardiac Care Units
Official Title Assessment of ADDICTion to Psychoactive Drug Use in Intensive Cardiac Care Units - The ADDICT-CCU Study
Brief Summary

Background:

Illicit drug use is a growing issue in Europe and leading cause of acute cardiac events in patients admitted to intensive cardiac care units. Indeed, cardiovascular complications are one of the main causes of death due to illicit drug use. However, its prevalence in patients hospitalized in intensive cardiac care units is unknown.

Objectives:

This large multicenter prospective study will assess the prevalence of illicit drug use in consecutive patients hospitalized in intensive cardiac care units by urine drug assay.

Eligibility:

  • Patient over 18 years old admitted to intensive Cardiac Care Unit (CCU) for any reason.
  • Without hospitalization for a planned interventional procedure.
  • Without hospitalization for more than 24 hours at any hospital facility before admission to the CCU.

Design:

  • Multicentre cohort study with a prospective enrolment of all consecutive patients admitted to the CCU to assess the prevalence of illicit drug use in 40 centers throughout France.
  • Participants will be screened with a physical exam, medical history and addiction survey.
  • Participants will be screened for drug use by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) and for tobacco by standardized exhaled carbon monoxide (CO) measurement with a CO-Check Pro device (Bedfont Scientific Ltd, Kent, UK).
  • Participants will be followed at 6 months of follow-up to assess the occurrence of cardiovascular events.
Detailed Description

Objective:

Illicit drug use is a growing issue in Europe. In France, the prevalence of the illicit use of any drug is 11.4% of the population, ahead of Italy (10.6%), the United Kingdom (8.7%) and Germany (7.8%).

Cardiovascular complications are one of the main causes of death due to psychoactive drug use with more than 100,000 deaths per year are due to psychoactive drug use in France. Although the use of illicit drugs may be involved in several acute cardiac events in patients admitted to intensive cardiac care units (CCU), its prevalence in patients hospitalized in CCU is unknown. Interestingly, the current guidelines recommend only a declarative survey to investigate psychoactive drug use but no systematic urine or plasma screening. However, the rate of underreporting of these illegal substances remains high. To our knowledge, no study has ever consecutively assessed the prevalence of psychoactive drug use using systematic urine or plasma screening at the time of CCU admission. Because illicit drug use is a potential cardiovascular risk factor, accurate drug screening may initiate addictology management, modify the treatment and improve patient prognosis after a cardiovascular event.

The aim of the prospective ADDICT-CCU study is to assess the prevalence of illicit drug use in consecutive patients hospitalized in intensive cardiac care units by urine drug assay.

Study population:

All consecutive patients over 18 years admitted to the CCU during a 3 week recruitment period in 40 centers. The main exclusion criteria will be hospitalization for a planned interventional procedure, dementia, or hospitalization for more than 24 hours at any hospital facility before admission to the CCU. Informed consent will be obtained from all participants.

Design:

The investigators will conduct a multicentre cohort study with a prospective enrolment of all consecutive patients admitted to the CCU to assess the prevalence of psychoactive drug use in 40 centers throughout France. Anonymized data supporting the findings of this study will be collected using CleanwebTM software.

Outcome Measures:

The primary outcome will be the prevalence of at least one illicit drug among all consecutive patients hospitalized in the CCU.

The following psychoactive drugs will be evaluated for all consecutive patients by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) within two hours of admission to the CCU: i) cannabinoids (tetrahydrocannabinol [THC]), including cannabis and hashish; ii) cocaine and metabolites, including cocaine and crack; iii) amphetamines; iv) MDMA; and v) heroin and other opioids.

In addition to the analysis of illicit drug use, the investigators will also use the NarcoCheck® urine drug assay to evaluate the associated use of the following psychoactive drugs: barbiturates, benzodiazepines, tricyclic antidepressant drugs, methadone and buprenorphine. Tobacco consumption will also be evaluated for each patient using a questionnaire with three choices: "never smoked," "smoking cessation" specifying the number of years, or "active smoking." Active smoking will also be systematically investigated in all patients using a standardized exhaled carbon monoxide (CO) measurement with a CO-Check Pro device (Bedfont Scientific Ltd, Kent, UK) on arrival, with a measure of > 3 parts per million (ppm) signifying active smoking. Every patient will be provided with relevant instructions regarding the urine drug assay and exhaled CO measurement, and trained investigators will conduct the tests.

Regarding the secondary outcomes, participants will be followed at 6 months of follow-up to assess the occurrence of cardiovascular events.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All consecutive patients over 18 years admitted to the CCU. The main exclusion criteria will be hospitalization for a planned interventional procedure, dementia, or hospitalization for more than 24 hours at any hospital facility before admission to the CCU. Informed consent will be obtained from all participants.
Condition
  • Intensive Care Unit Syndrome
  • Drug Abuse
  • Substance-Related Disorders
  • Cardiovascular Events
  • Cardiac Disease
Intervention
  • Other: urine test
    The following illicit drugs will be evaluated for all consecutive patients by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) within two hours of admission to the ICCU: i) cannabinoids (tetrahydrocannabinol [THC]), including cannabis and hashish; ii) cocaine and metabolites, including cocaine and crack; iii) amphetamines; iv) MDMA; and v) heroin and other opioids. In addition to the analysis of psychoactive drug use, the investigators will also use the NarcoCheck® urine drug assay to evaluate the associated use of the following psychostimulant drugs: barbiturates, benzodiazepines, tricyclic antidepressant drugs, methadone and buprenorphine.
  • Other: Fagerström questionnaire
    Tobacco consumption will also be evaluated for each patient using a Fagerström questionnaire.
  • Other: Exhaled carbon monoxide (CO) measurement
    Active smoking will also be systematically investigated in all patients using a standardized exhaled carbon monoxide (CO) measurement with a CO-Check Pro device (Bedfont Scientific Ltd, Kent, UK) on arrival, with a measure of > 3 parts per million (ppm) signifying active smoking.
Study Groups/Cohorts CCU patients
All consecutive patients over 18 years admitted to the CCU.
Interventions:
  • Other: urine test
  • Other: Fagerström questionnaire
  • Other: Exhaled carbon monoxide (CO) measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 22, 2021)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient over 18 years old admitted to Cardiac Intensive Care Unit (CCU) for any reason.
  • Oral informed consent.

Exclusion Criteria:

  • Hospitalization for a planned interventional procedure (percutaneous coronary intervention, coronary artery bypass graft surgery, transcatheter aortic valve implantation…).
  • Dementia.
  • Hospitalization for more than 24 hours at any hospital facility before admission to the CCU.
  • Patient under legal protection without the consent of the legal representative.
  • Patient with no social security.
  • Declining participation.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Patrick HENRY, MD,PhD +33 1 49 95 82 24 patrick.henry@aphp.fr
Contact: Théo PEZEL, MD +33 1 49 95 86 74 theo.pezel@aphp.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT05063097
Other Study ID Numbers APHP190870
2021-A00702-39 ( Other Identifier: ANSM - IDRCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Fondation Coeur et Recherche
Investigators
Study Director: Jean-Guillaume DILLINGER, MD,PhD Lariboisière Hospital, APHP, Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date June 2021