Clinical and Atherosclerotic Characteristics of Patients With ACS Associated With Cocaine Use

NCT06177860 | Unknown

• 1 other identifier: 00982023
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Cocaine use has increased in our country in recent decades. It is associated with cardiovascular events and early atherosclerotic disease. Acute coronary syndrome (ACS) is one of its most frequent and serious manifestations. There is a lack of scientific information on ACS associated with acute and chronic cocaine use in Argentina. This study aims to describe the socioeconomic, clinical, and coronary angiographic characteristics, as well as the extent of atherosclerotic disease in patients with ACS associated with cocaine use, and to compare them with ACS not associated with cocaine use. Methods: We propose an observational, analytical, single-center, two-phase study, with a retrospective and a prospective component. Patients with a diagnosis of ACS admitted to the coronary care unit of a high-complexity public hospital will be included. Clinical, biochemical, coronary angiographic, extracoronary atherosclerotic disease extension and prognostic variables will be described. These variables will be compared between patients with cocaine-associated ACS and non-cocaine-associated ACS.

Conditions

Myocardial Infarction; Acute Coronary Syndrome; Cocaine Use; Cocaine Abuse

Keywords

Myocardial infarction; Acute Coronary Syndrome; Cocaine Use; Cocaine Abuse

Outcome Measures

Primary Outcomes (4)

• Complexity and extent of coronary heart disease

  The Syntax Score (Synergy Between PCI With Taxus and Cardiac Surgery) will be quantified in patients with and without a history of cocaine use. A higher Syntax Score indicates a more complex coronary disease as well as worse prognosis. Score values of 0 to 22 are considered low complexity, 23 to 32 moderate complexity and \>32 high complexity.

  During coronary angiography

• Clinical presentation as STEAMI, or NSTEAMI or unstable angina

  Differences between groups in clinical presentation as STEAMI, NSTEAMI or unstable angina will be based on the findings of the first electrocardiogram registred during admision, following the Fourth Universal Definition of Myocardial Infarction.

  Up to 24 hours of admission

• Mortality

  Total mortality

  During hospitalization (up to 30 days)

• Severe complications

  A combined ouctome including: resuscitated cardiac arrest, complex arrhythmia requiring electrical cardioversion, use of inotropes, or mechanical ventilatory support.

  During hospitalization (up to 30 days)

Secondary Outcomes (5)

• Extent of atherosclerotic vascular disease

  During hospitalization (up to 30 days)

• Myocardial damage

  During hospitalization (up to 30 days)

• Socioeconomic factors: unemployment

  During hospitalization (up to 30 days)

• Socioeconomic factors: health insurance

  During hospitalization (up to 30 days)

• Socioeconomic factors: highest level of formal education

  During hospitalization (up to 30 days)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The biological sex and self-representation of gender identity of the patients will be recorded.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute coronary syndrome admitted to the coronary care unit of a high-complexity hospital.

You may qualify if:

• Age ≥18
• Hospitalization due to diagnosis of ACS, made by the treating medical team.
• For the prospective stage, it will be added:
• Acceptance to participate in the study and willingness to sign the informed consent.

You may not qualify if:

• Patients who, due to their clinical condition, cannot be interviewed to determine their history of cocaine use.

Sponsors & Collaborators

• Hospital El Cruce: lead

Study Sites (1)

Hospital El Cruce

San Juan Bautista, Buenos Aires, 1888, Argentina

RECRUITING

Related Publications (8)

• Kim ST, Park T. Acute and Chronic Effects of Cocaine on Cardiovascular Health. Int J Mol Sci. 2019 Jan 29;20(3):584. doi: 10.3390/ijms20030584.

  PMID: 30700023 RESULT

• Lange RA, Hillis LD. Cardiovascular complications of cocaine use. N Engl J Med. 2001 Aug 2;345(5):351-8. doi: 10.1056/NEJM200108023450507. No abstract available.

  PMID: 11484693 RESULT

• Gatto L, Frati G, Biondi-Zoccai G, Versaci F. Cocaine and acute coronary syndromes: Novel management insights for this clinical conundrum. Int J Cardiol. 2018 Jun 1;260:16-17. doi: 10.1016/j.ijcard.2018.03.011. No abstract available.

  PMID: 29622433 RESULT

• Rezkalla SH, Kloner RA. Cocaine-induced acute myocardial infarction. Clin Med Res. 2007 Oct;5(3):172-6. doi: 10.3121/cmr.2007.759.

  PMID: 18056026 RESULT

• DeFilippis EM, Singh A, Divakaran S, Gupta A, Collins BL, Biery D, Qamar A, Fatima A, Ramsis M, Pipilas D, Rajabi R, Eng M, Hainer J, Klein J, Januzzi JL, Nasir K, Di Carli MF, Bhatt DL, Blankstein R. Cocaine and Marijuana Use Among Young Adults With Myocardial Infarction. J Am Coll Cardiol. 2018 Jun 5;71(22):2540-2551. doi: 10.1016/j.jacc.2018.02.047. Epub 2018 Mar 10.

  PMID: 29535062 RESULT

• Ma I, Genet T, Clementy N, Bisson A, Herbert J, Semaan C, Bouteau J, Angoulvant D, Ivanes F, Fauchier L. Outcomes in patients with acute myocardial infarction and history of illicit drug use: a French nationwide analysis. Eur Heart J Acute Cardiovasc Care. 2021 Dec 6;10(9):1027-1037. doi: 10.1093/ehjacc/zuab073.

  PMID: 34453835 RESULT

• Aquaro GD, Gabutti A, Meini M, Prontera C, Pasanisi E, Passino C, Emdin M, Lombardi M. Silent myocardial damage in cocaine addicts. Heart. 2011 Dec;97(24):2056-62. doi: 10.1136/hrt.2011.226977. Epub 2011 Jun 20.

  PMID: 21690608 RESULT

• US Preventive Services Task Force; Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, Caughey AB, Curry SJ, Donahue K, Doubeni CA, Epling JW Jr, Kubik M, Ogedegbe G, Pbert L, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Unhealthy Drug Use: US Preventive Services Task Force Recommendation Statement. JAMA. 2020 Jun 9;323(22):2301-2309. doi: 10.1001/jama.2020.8020.

  PMID: 32515821 RESULT

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome; Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Maximiliano de Abreu, PhD

  Hospital El Cruce

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maximiliano de Abreu, PhD

CONTACT

5491156577631; maxideabreu@gmail.com

Ezequiel Lerech, MD

CONTACT

5491151336293; ezequiellerech@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 20, 2023
• Study Start: November 17, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

AR (1)