- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06177860
Clinical and Atherosclerotic Characteristics of Patients With ACS Associated With Cocaine Use
Clinical Presentation, Coronary Angiographic Findings and Extent of Atherosclerotic Disease in Patients With Acute Coronary Syndrome Associated With Cocaine Use
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.
Study Overview
Status
Detailed Description
General objective:
- To identify socioeconomic, clinical, electrocardiographic, coronary angiographic, and atherosclerotic disease extent differences between ACS patients with a history of cocaine use and those without cocaine use.
Specific objectives:
To characterize and compare between both groups:
- Clinical characteristics.
- Coronary angiographic findings
- Extent of myocardial damage related and unrelated to ACS.
- Severe complications during hospitalization (mortality, resuscitated cardiac arrest, arrhythmias, use of IV inotropics and mechanical ventilatory support).
- Extent of noncoronary vascular disease.
Design:
A quantitative approach will be used, with an observational, analytical, single-center, two-stage design. In the retrospective stage, cases admitted from April 2019 to June 2023 for ACS will be included, based on data collected in the routine practice of the coronary care unit. In the prospective stage, all cases admitted to our institution for ACS from November 1, 2023, to November 2024 will be included.
Inclusion criteria:
- Age ≥18 years.
- Hospitalization with a diagnosis of ACS. For the prospective stage, acceptance to participate in the study and informed consent will be added.
Exclusion criteria:
Retrospective stage: patients who were not questioned about cocaine use. Prospective stage: patients who could not be interviewed to determine their history of cocaine use because of their clinical condition.
Procedures:
Two groups will be defined according to the history of cocaine use: cocaine-associated ACS and non-cocaine-associated ACS.
For the retrospective phase, all patients admitted to the coronary unit for ACS in the period established for the study will be reviewed. It is standard practice to ask about cardiovascular risk factors, history of substance use, including cocaine, and other clinical history. We expect to correctly identify cases of ACS associated and not associated with cocaine use.
In all cases included in both stages, the clinical, electrocardiographic, biochemical, and coronary angiographic characteristics and the extent of extra coronary atherosclerotic disease, complications, and prognosis will be described and compared between the two groups.
In the prospective phase of the study, where medically necessary, cardiac magnetic resonance imaging (MRI) will be performed to assess the extent of ACS-related and non-ACS-related myocardial necrosis and edema. Cardiac MRI findings will be compared between groups.
Clinical follow-up will be limited to hospitalization.
Main study variables and measurement instruments:
- ACS associated with cocaine and other substance use: They will be revealed by questioning, following evidence-based recommendations. ACS associated with cocaine use will be considered for those patients who verbally report the history.
- Clinical variables: Will be recorded on admission: age, weight and height, blood pressure, heart rate, cardiovascular risk factors (hypertension, diabetes, dyslipidemia, smoking), use of other substances (marijuana, using the same criteria as for cocaine), cardiovascular history (myocardial infarction, stroke, coronary revascularization, peripheral vascular disease, and heart failure).
- Electrocardiographic variables: 12-lead electrocardiograms will be performed on admission and during hospitalization to classify ACS as ST-elevation myocardial infarction (STEMI) or non-ST-elevation acute coronary syndrome (NSTEMI), to describe the location of ACS and to detect complications.
- Biochemical: a general and specific biochemical evaluation of ACS (CPK, CK mb, troponin, Pro BNP) will be performed. Peak enzymatic elevation of CPK and troponins will be used as a biochemical indicator of the extent of myocardial necrosis.
- Echocardiography: an assessment of ventricular function will be performed by measuring ejection fraction, diastolic dysfunction, and wall motility disorders. The presence of mechanical complications will be evaluated by this method.
- Extent and complexity of coronary atherosclerotic disease: coronary angiography will be used to define the extent and complexity of coronary lesions using the SYNTAX score. Also, an assessment of acute pathophysiological mechanisms related to ACS (thrombus, spasm, coronary dissection, as dichotomous variables: present or absent) will be performed.
- Extent of extra coronary atherosclerotic disease: ankle-brachial index (ABI) will be used as an indicator of peripheral vascular disease of the lower limbs. The presence, morphology, and extent of atherosclerotic plaque at the carotid level will be determined by carotid Doppler ultrasound.
- MRI: the degree of myocardial necrosis and edema related and unrelated to ACS will be assessed, as a manifestation of acute and chronic myocardial damage associated with ACS and cocaine use.
Statistical analysis:
Continuous variables will be described as mean and standard deviation in the case of normal distribution or median and interquartile range, and categorical variables will be described as numbers and percentages. Differences between groups for continuous variables will be evaluated with the T-test for variables with a normal distribution, and the Kruskal-Wallis test for nonparametric variables. Categorical variables will be compared using the chi-squared test and Fisher's exact test. Multiple logistic regression models will be developed to determine the independent association between cocaine use and the dependent variables of interest. Statistical analysis will be performed with the R Studio program.
Procedures to ensure the ethical aspects of the research:
All study procedures will be conducted following international ethical norms and standards to respect participant's rights and protect confidentiality.
In addition, all study procedures conform to the principles of the Declaration of Helsinki and CIOMS guidelines.
The research protocol was submitted for evaluation and approved by the Research Ethics Committee (REC) of the El Cruce Hospital.
For the retrospective stage, the research team will make every effort to contact patients who meet the inclusion criteria to request informed consent for their data to be analyzed, undertaking to guarantee the anonymity of personal data. For the prospective stage of the study, potentially eligible individuals will receive a detailed explanation of the objectives and procedures before enrollment. They will be asked to sign the informed consent form (ICF). Participation is voluntary and anonymity and confidentiality of information are compromised. At this stage, only cases that have signed the ICF will be included.
All information related to the study will be securely archived with access codes only available to the research team. Personal identification records will be kept separately from study records identified by code number. Data collection forms will be coded to maintain participant confidentiality. The local database will be protected with a password-protected access system. Study key codes linking participant identification numbers to other identifying information will be stored in a separate, locked file in a limited access area.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maximiliano de Abreu, PhD
- Phone Number: 5491156577631
- Email: maxideabreu@gmail.com
Study Contact Backup
- Name: Ezequiel Lerech, MD
- Phone Number: 5491151336293
- Email: ezequiellerech@gmail.com
Study Locations
-
-
Buenos Aires
-
Florencio Varela, Buenos Aires, Argentina, 1888
- Recruiting
- Hospital El Cruce
-
Contact:
- Ezequiel Lerech, MD
- Phone Number: 5491151336293
- Email: ezequiellerech@gmail.com
-
Contact:
- Maximiliano de Abreu, PhD
- Phone Number: +5491156577631
- Email: maxideabreu@gmail.com
-
Principal Investigator:
- Maximiliano de Abreu, PhD
-
Sub-Investigator:
- Ezequiel Lerech, MD
-
Sub-Investigator:
- Santiago Torrroba, MD
-
Sub-Investigator:
- Juan Bacigalupe, MD
-
Sub-Investigator:
- Mauro Rossi Prat, MD
-
Sub-Investigator:
- Diego Kyle, MD
-
Sub-Investigator:
- Heraldo D´Imperio, MD
-
Sub-Investigator:
- Natalia Vensentini, MD
-
Sub-Investigator:
- Graciela Reyes, MD
-
Sub-Investigator:
- Pablo Kociubinski, MD
-
Sub-Investigator:
- Raúl Solernó, MD
-
Sub-Investigator:
- Laura Antonietti, MD
-
Sub-Investigator:
- Mariani Javier, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who, due to their clinical condition, cannot be interviewed to determine their history of cocaine use.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complexity and extent of coronary heart disease
Time Frame: During coronary angiography
|
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
|
Mortality
Time Frame: During hospitalization (up to 30 days)
|
Total mortality
|
During hospitalization (up to 30 days)
|
Severe complications
Time Frame: During hospitalization (up to 30 days)
|
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)
|
Clinical presentation as STEAMI, or NSTEAMI or unstable angina
Time Frame: Up to 24 hours of admission
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extent of atherosclerotic vascular disease
Time Frame: During hospitalization (up to 30 days)
|
The extent of extracoronary atherosclerotic vascular disease will be quantified by vascular Doppler of the carotids and lower limbs
|
During hospitalization (up to 30 days)
|
Myocardial damage
Time Frame: During hospitalization (up to 30 days)
|
The extent of ischemic and non-ischemic myocardial damage will be quantified by cardiac MRI.
|
During hospitalization (up to 30 days)
|
Socioeconomic factors: unemployment
Time Frame: During hospitalization (up to 30 days)
|
Unemployment (as a proportion) will be compared between patients with and without a history of cocaine use.
|
During hospitalization (up to 30 days)
|
Socioeconomic factors: health insurance
Time Frame: During hospitalization (up to 30 days)
|
Health insurance ownership (as a proportion) will be compared between patients with and without a history of cocaine use.
|
During hospitalization (up to 30 days)
|
Socioeconomic factors: highest level of formal education
Time Frame: During hospitalization (up to 30 days)
|
The highest level of formal education (as an ordinal variable from kindergarten = 1 to college = 8) will be compared between patients with and without a history of cocaine use.
|
During hospitalization (up to 30 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maximiliano de Abreu, PhD, Hospital El Cruce
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: N Engl J Med 2001 Nov 8;345(19):1432.
- 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.
- Rezkalla SH, Kloner RA. Cocaine-induced acute myocardial infarction. Clin Med Res. 2007 Oct;5(3):172-6. doi: 10.3121/cmr.2007.759.
- 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.
- 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.
- 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. Erratum In: Heart. 2011 Dec;97(24):2061.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00982023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
-
Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom