Assessment of ADDICTion to Psychoactive Drug Use in Intensive Cardiac Care Units - The ADDICT-CCU Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- Prevalence of psychoactive drug use assessed by urine drug assay at the time of patient admission.
Study Overview
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Duration of the hospitalization(Up to 3 months)
- The occurrence of cardiovascular events(24 months of follow-up)
- Combined major adverse clinical events (MACE).(24 months of follow-up)
- All cause mortality(24 months of follow-up)
- In-hospital major adverse events (MAE)(Up to 3 months)