Addiction in Intensive Cardiac Care Units

NCT05063097 | Unknown

• 2 other identifiers: APHP1908702021-A00702-39
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of psychoactive drug use assessed by urine drug assay at the time of patient admission.

  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.

  Day 0

Secondary Outcomes (8)

• In-hospital major adverse events (MAE)

  Up to 3 months

• Duration of the hospitalization

  Up to 3 months

• Combined major adverse clinical events (MACE).

  12 months of follow-up

• All cause mortality

  12 months of follow-up

• The occurrence of cardiovascular events

  12 months of follow-up

Study Arms (1)

CCU patients

All consecutive patients over 18 years admitted to the CCU.

Other: urine test; Other: Fagerström questionnaire; Other: Exhaled carbon monoxide (CO) measurement

Interventions

urine test OTHER

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.

CCU patients

Fagerström questionnaire OTHER

Tobacco consumption will also be evaluated for each patient using a Fagerström questionnaire.

CCU patients

Exhaled carbon monoxide (CO) measurement OTHER

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.

CCU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation Coeur et Recherche: collaborator

Study Sites (1)

CHU Lariboisière, APHP, Cardiology

Paris, Île-de-France Region, 75010, France

Location

Related Publications (9)

• Fauvel C, Dillinger JG, Bochaton T, Levasseur T, El Ouahidi A, Zakine C, El Hadad A, Mansencal N, Noirclerc N, Goralski M, Thuaire C, Mewton N, Schurtz G, Lim P, Pommier T, Lemarchand L, Laissac Q, Lamblin N, Boukertouta T, Logeart D, Cohen-Solal A, Henry P, Pezel T; ADDICT-ICCU Investigators. In-hospital and 1 year incremental prognostic value of drug abuse detection in acute heart failure. ESC Heart Fail. 2025 Aug;12(4):2736-2748. doi: 10.1002/ehf2.15118. Epub 2025 May 21.

  PMID: 40396434 DERIVED

• Weizman O, Hamzi K, Henry P, Schurtz G, Hauguel-Moreau M, Trimaille A, Bedossa M, Dib JC, Attou S, Boukertouta T, Boccara F, Pommier T, Lim P, Bochaton T, Millischer D, Merat B, Picard F, Grinberg N, Sulman D, Pasdeloup B, El Ouahidi Y, Goncalves T, Vicaut E, Dillinger JG, Toupin S, Pezel T; ADDICT-ICCU Investigators. Machine learning score to predict in-hospital outcomes in patients hospitalized in cardiac intensive care unit. Eur Heart J Digit Health. 2024 Dec 20;6(2):218-227. doi: 10.1093/ehjdh/ztae098. eCollection 2025 Mar.

  PMID: 40110223 DERIVED

• Sibilia B, Toupin S, Bouali N, Brette JB, Ramonatxo A, Schurtz G, Hamzi K, Trimaille A, Gall E, Piliero N, Unger A, Andrieu S, Goncalves T, Picard F, Roule V, Roubille F, Houssany-Pissot S, Bouchot O, Aboyans V, Vasram RR, Bochaton T, Logeart D, Solal AC, Cartailler J, Mebazaa A, Dillinger JG, Henry P, Pezel T. Supervised machine learning including environmental factors to predict in-hospital outcomes in acute heart failure patients. Eur Heart J Digit Health. 2024 Dec 16;6(2):190-199. doi: 10.1093/ehjdh/ztae094. eCollection 2025 Mar.

  PMID: 40110211 DERIVED

• Hamzi K, Gall E, Roubille F, Trimaille A, Elbaz M, El Ouahidi A, Noirclerc N, Fard D, Lattuca B, Fauvel C, Goralski M, Alvain S, Chaib A, Piliero N, Schurtz G, Pommier T, Bouleti C, Tron C, Bonnet G, Nhan P, Auvray S, Lequipar A, Dillinger JG, Vicaut E, Henry P, Toupin S, Pezel T; ADDICT-ICCU Investigators. Phenotypic clustering of patients hospitalized in intensive cardiac care units: Insights from the ADDICT-ICCU study. Arch Cardiovasc Dis. 2024 Jun-Jul;117(6-7):392-401. doi: 10.1016/j.acvd.2024.03.004. Epub 2024 May 23.

  PMID: 38834393 DERIVED

• Fauvel C, Dillinger JG, Bouleti C, Trimaille A, Tron C, Chaussade AS, Thuaire C, Delmas C, Boccara A, Roule V, Millischer D, Thevenet E, Meune C, Stevenard M, Charbonnel C, Maitre Ballesteros L, Pommier T, El Ouahidi A, Swedsky F, Martinez D, Hauguel-Moreau M, Schurtz G, Coisne A, Dupasquier V, Bochaton T, Gerbaud E, Puymirat E, Henry P, Pezel T; ADDICT-ICCU Investigators. Tricuspid annular plane systolic excursion over systolic pulmonary artery pressure prognostic value for in-hospital adverse events in patients hospitalized for acute coronary syndrome. Eur Heart J Cardiovasc Imaging. 2024 Aug 26;25(9):1244-1254. doi: 10.1093/ehjci/jeae110.

  PMID: 38650518 DERIVED

• Fauvel C, Dillinger JG, Rossanaly Vasram R, Bouleti C, Logeart D, Roubille F, Meune C, Ohlmann P, Bonnefoy-Coudraz E, Albert F, Attou S, Boukhris M, Pommier T, Merat B, Noirclerc N, Bouali N, Aghezzaf S, Schurtz G, Mansencal N, Andrieu S, Henry P, Pezel T; ADDICT-ICCU Investigators. In-hospital prognostic value of TAPSE/sPAP in patients hospitalized for acute heart failure. Eur Heart J Cardiovasc Imaging. 2024 Jul 31;25(8):1099-1108. doi: 10.1093/ehjci/jeae059.

  PMID: 38428980 DERIVED

• Clement A, Dillinger JG, Ramonatxo A, Roule V, Picard F, Thevenet E, Swedzky F, Hauguel-Moreau M, Sulman D, Stevenard M, Amri N, Martinez D, Maitre-Ballesteros L, Landemaine T, Coppens A, Bouali N, Guiraud-Chaumeil P, Gall E, Lequipar A, Henry P, Pezel T. In-hospital prognosis of acute ST-elevation myocardial infarction in patients with recent recreational drug use. Eur Heart J Acute Cardiovasc Care. 2024 May 7;13(4):324-332. doi: 10.1093/ehjacc/zuae024.

  PMID: 38381068 DERIVED

• Dillinger JG, Pezel T, Delmas C, Schurtz G, Trimaille A, Piliero N, Bouleti C, Lattuca B, Andrieu S, Fabre J, Rossanaly Vasram R, Dib JC, Aboyans V, Fauvel C, Roubille F, Gerbaud E, Boccara A, Puymirat E, Toupin S, Vicaut E, Henry P; ADDICT-ICCU trial. Carbon monoxide and prognosis in smokers hospitalised with acute cardiac events: a multicentre, prospective cohort study. EClinicalMedicine. 2024 Jan 3;67:102401. doi: 10.1016/j.eclinm.2023.102401. eCollection 2024 Jan.

  PMID: 38261914 DERIVED

• Pezel T, Dillinger JG, Trimaille A, Delmas C, Piliero N, Bouleti C, Pommier T, El Ouahidi A, Andrieu S, Lattuca B, Rossanaly Vasram R, Fard D, Noirclerc N, Bonnet G, Goralski M, Elbaz M, Deney A, Schurtz G, Docq C, Roubille F, Fauvel C, Bochaton T, Aboyans V, Boccara F, Puymirat E, Batisse A, Steg G, Vicaut E, Henry P; ADDICT-ICCU Investigators. Prevalence and impact of recreational drug use in patients with acute cardiovascular events. Heart. 2023 Oct 12;109(21):1608-1616. doi: 10.1136/heartjnl-2023-322520.

  PMID: 37582633 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Heart Diseases; Marijuana Abuse

Interventions

Urinalysis; Weights and Measures

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Officials

• Jean-Guillaume DILLINGER, MD,PhD

  Lariboisière Hospital, APHP, Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: September 30, 2021
• Study Start: April 6, 2021
• Primary Completion: June 6, 2021
• Study Completion: April 1, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)