Clinical trial NCT05063097: Addiction in Intensive Cardiac Care Units
Official title: Assessment of ADDICTion to Psychoactive Drug Use in Intensive Cardiac Care Units - The ADDICT-CCU Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intensive Care Unit Syndrome
Drug Abuse
Substance-Related Disorders
Cardiovascular Events
Cardiac Disease
Keywords: Prevalence
Drug Abuse
Illicit drug use
Substance-Related Disorders
Intensive cardiac care unit
Cannabis
Cocaine
Cardiovascular events
Psychoactive drug use
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation Coeur et Recherche
First posted: 2021-09-30
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Prevalence of psychoactive drug use assessed by urine drug assay at the time of patient admission.
timeFrame: Day 0
Secondary outcomes:
measure: In-hospital major adverse events (MAE)
timeFrame: Up to 3 months
measure: Duration of the hospitalization
timeFrame: Up to 3 months
measure: Combined major adverse clinical events (MACE).
timeFrame: 12 months of follow-up
measure: All cause mortality
timeFrame: 12 months of follow-up
measure: The occurrence of cardiovascular events
timeFrame: 12 months of follow-up
measure: Combined major adverse clinical events (MACE).
timeFrame: 24 months of follow-up
measure: All cause mortality
timeFrame: 24 months of follow-up
measure: The occurrence of cardiovascular events
timeFrame: 24 months of follow-up
Other outcomes:
Locations:
city: Paris
country: France
facility: CHU Lariboisière, APHP, Cardiology
state: Ile De France
Study officials:
affiliation: Lariboisière Hospital, APHP, Paris
name: Jean-Guillaume DILLINGER, MD,PhD
role: STUDY_DIRECTOR
References: