ST Elevation Myocardial InfarctionNCT04090216
Outcome of Primary PCI in STEMI Addict Patients
An observational study of ST Elevation Myocardial Infarction, run by Assiut University.
Trial summary
The goal of this study is to Identify the in-hospital outcome of primary PCI in treatment of STEMI in addict patients in comparison to non-addict patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- Primary Percutaneous Coronary Intervention
- Type of treatment
- Medical device
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: : The study will include all patients presented with ST elevation myocardial infarction undergoing primary PCI in Assuit University Hospital , Patients will be classified into 2 groups : Group A:patients proved to be addicts by DSM-5 criteria of WHO for addiction \& urine tests. Group B: Non-addict patients .
Who may be able to join
- All patients of all categories of ages who will be presented with ST elevation myocardial infarction and undergoing primary PCI in Assuit University Hospital.
Who cannot join
- -Patients who present with STEMI but will not undergo primary PCI.
About this study
Official title: In-Hospital Outcome of Primary Percutaneous Coronary Intervention in Addict ST Elevation Myocardial Infarction Patients in Assuit University Hospital.
- The goal of this study is to Identify the in-hospital outcome of primary PCI in treatment of STEMI in addict patients in comparison to non-addict patients.
Read the detailed description
Myocardial infarction (MI), is a type of acute coronary syndrome, in which there is damage to the cardiac muscle as demonstrated by increased cardiac Troponin levels in the setting of acute ischemia (1). Myocardial infarction (MI) is a fatal disease that is caused by block in the oxygen supply of blood vessels of the heart muscle, leading to permanent heart muscle damage and death of its cells. According to world health organization (WHO) report published in 2014, 68% of global deaths annually related to non communicable diseases, Cardiovascular diseases constitute 31% of these deaths denoting that they are the leading cause of death (2). Risk factors of cardiovascular diseases include behavioral factors as eating un healthy food, smoking, alcohol intake, and other substance abuse.
Regarding management of MI, There have been several studies that have shown the superiority of percutaneous coronary intervention (PCI) as a treatment for ST-elevation myocardial infarction (STEMI) when compared with thrombolytic therapy in terms of reducing mortality rate and recurrence of myocardial infarction (MI) [3-5].
Regarding Drug abuse cardiovascular effects. It depends on the drug, dose, and route of administration, cardiovascular consequences can range from innocuous side effects, to life threatening ventricular arrhythmias and myocardial infarction.
Sympathomimetic drugs like amphetamines cause an increase in release of peripheral catecholamines stimulating increases in heart rate, systemic vascular resistance, and cardiac contractility, thus resulting in augmentation of cardiac output and blood pressure. In contrast, several drugs are directly cardiodepressant in the acute setting, and many drugs of both types are cardiotoxic causing cardiomyopathy and congestive heart failure with long-term use.
Changes in the balance of myocardial oxygen supply and demand with drug use can lead to myocardial ischemia. For example, cocaine increases oxygen demand in the myocardium while simultaneously decreasing supply by inducing epicardial coronary vasoconstriction. Modulation of lipid profiles, coagulation factors, platelet function, and inflammation further heighten the risk of cardiac ischemic events in patients using these drugs.
Many recreational drugs are arrhythmogenic in the acute setting or during abstinence/withdrawal. Mechanisms of arrhythmias are complex and likely result from interplay between the direct effects of drugs, electrolyte derangements, sympathetic nervous alterations, and cardiac ischemia.(6)
Substance Use Disorders (SUD) are considered to be prevalent In Middle Eastern Arab countries, particularly Egypt, but there is scarce information on the problem of patients with substance abuse or dependence attending emergency rooms in general hospitals.
In across sectional study done in EL Mansoura University in 2012, Among patients with substance abuse, cannabis ranked first (3.6%) then tramadol 1.8%, polysubstance1.7%, followed by stimulants group (1.3%), alcohol (1.1%), and finally anticholinergics (0.5%) and volatile substances (0.3%). Urine toxicology shows that 30% used at least one of these illicit drugs: (20%) tested positive for cannabis, (6%) had a positive urine screen for amphetamine, and (10%) tested positive for opiates.(7)
Prior studies have reported discrepant results on the association between substance use disorders and access to Primary PCI after acute myocardial infarct (AMI) [8]. Druss and colleagues showed that patients with SUDs aged 65 and older in acute care non-governmental hospitals in the United States were less likely than those with neither mental nor substance use disorder to receive cardiac catheterization after acute MI [9]. Young reported data stratified by age, indicating that patients with SUDs both younger and older than 65 years have lower rates of cardiac procedures and higher rates of in-hospital mortality compared with those with neither mental nor substance use disorders [10]. Most recently, Jones and colleagues published results from an analysis of administrative data from a large commercially insured sample of all ages, adjusting for comorbidities.(11) They obtained an unexpected result: those with SUDs were more likely to receive percutaneous coronary intervention (PCI) in comparison to those with neither mental nor substance use disorders.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Primary Percutaneous Coronary Intervention
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Percutaneous Coronary InterventionDevice
Primary PCI will be done for patients with STEMI in both groups of patients
| Study group | Role | What they receive |
|---|---|---|
| Addict patients | patients with substance use disorders presented with STEMI \& undergoing Primary PCI Receives: Device: Primary Percutaneous Coronary Intervention | |
| Non Addict patients | patients without substance use disorders presented with STEMI \& undergoing Primary PCI Receives: Device: Primary Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome of primary PCI in addict STEMI patients
Identify the in-hospital outcome of primary PCI in treatment of STEMI in addict patients in comparison to non-addict patients.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdalla Aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090216
- Sponsor's protocol ID
- Primary PCI
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2019
- Last updated
- 16 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Hospital Outcome of Primary Percutaneous Coronary Intervention in Addict ST Elevation Myocardial Infarction Patients in Assuit University Hospital.
- ClinicalTrials.gov ID
- NCT04090216
- Acronym / sponsor ID
- Primary PCI
- Conditions
- ST Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The goal of this study is to Identify the in-hospital outcome of primary PCI in treatment of STEMI in addict patients in comparison to non-addict patients.
Detailed description
Myocardial infarction (MI), is a type of acute coronary syndrome, in which there is damage to the cardiac muscle as demonstrated by increased cardiac Troponin levels in the setting of acute ischemia (1). Myocardial infarction (MI) is a fatal disease that is caused by block in the oxygen supply of blood vessels of the heart muscle, leading to permanent heart muscle damage and death of its cells. According to world health organization (WHO) report published in 2014, 68% of global deaths annually related to non communicable diseases, Cardiovascular diseases constitute 31% of these deaths denoting that they are the leading cause of death (2). Risk factors of cardiovascular diseases include behavioral factors as eating un healthy food, smoking, alcohol intake, and other substance abuse.
Regarding management of MI, There have been several studies that have shown the superiority of percutaneous coronary intervention (PCI) as a treatment for ST-elevation myocardial infarction (STEMI) when compared with thrombolytic therapy in terms of reducing mortality rate and recurrence of myocardial infarction (MI) [3-5].
Regarding Drug abuse cardiovascular effects. It depends on the drug, dose, and route of administration, cardiovascular consequences can range from innocuous side effects, to life threatening ventricular arrhythmias and myocardial infarction.
Sympathomimetic drugs like amphetamines cause an increase in release of peripheral catecholamines stimulating increases in heart rate, systemic vascular resistance, and cardiac contractility, thus resulting in augmentation of cardiac output and blood pressure. In contrast, several drugs are directly cardiodepressant in the acute setting, and many drugs of both types are cardiotoxic causing cardiomyopathy and congestive heart failure with long-term use.
Changes in the balance of myocardial oxygen supply and demand with drug use can lead to myocardial ischemia. For example, cocaine increases oxygen demand in the myocardium while simultaneously decreasing supply by inducing epicardial coronary vasoconstriction. Modulation of lipid profiles, coagulation factors, platelet function, and inflammation further heighten the risk of cardiac ischemic events in patients using these drugs.
Many recreational drugs are arrhythmogenic in the acute setting or during abstinence/withdrawal. Mechanisms of arrhythmias are complex and likely result from interplay between the direct effects of drugs, electrolyte derangements, sympathetic nervous alterations, and cardiac ischemia.(6)
Substance Use Disorders (SUD) are considered to be prevalent In Middle Eastern Arab countries, particularly Egypt, but there is scarce information on the problem of patients with substance abuse or dependence attending emergency rooms in general hospitals.
In across sectional study done in EL Mansoura University in 2012, Among patients with substance abuse, cannabis ranked first (3.6%) then tramadol 1.8%, polysubstance1.7%, followed by stimulants group (1.3%), alcohol (1.1%), and finally anticholinergics (0.5%) and volatile substances (0.3%). Urine toxicology shows that 30% used at least one of these illicit drugs: (20%) tested positive for cannabis, (6%) had a positive urine screen for amphetamine, and (10%) tested positive for opiates.(7)
Prior studies have reported discrepant results on the association between substance use disorders and access to Primary PCI after acute myocardial infarct (AMI) [8]. Druss and colleagues showed that patients with SUDs aged 65 and older in acute care non-governmental hospitals in the United States were less likely than those with neither mental nor substance use disorder to receive cardiac catheterization after acute MI [9]. Young reported data stratified by age, indicating that patients with SUDs both younger and older than 65 years have lower rates of cardiac procedures and higher rates of in-hospital mortality compared with those with neither mental nor substance use disorders [10]. Most recently, Jones and colleagues published results from an analysis of administrative data from a large commercially insured sample of all ages, adjusting for comorbidities.(11) They obtained an unexpected result: those with SUDs were more likely to receive percutaneous coronary intervention (PCI) in comparison to those with neither mental nor substance use disorders.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Addict patients | – | Device: Primary Percutaneous Coronary Interventionpatients with substance use disorders presented with STEMI \& undergoing Primary PCI |
| Non Addict patients | – | Device: Primary Percutaneous Coronary Interventionpatients without substance use disorders presented with STEMI \& undergoing Primary PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- : The study will include all patients presented with ST elevation myocardial infarction undergoing primary PCI in Assuit University Hospital , Patients will be classified into 2 groups : Group A:patients proved to be addicts by DSM-5 criteria of WHO for addiction \& urine tests. Group B: Non-addict patients .
Key inclusion criteria (1 listed)
- All patients of all categories of ages who will be presented with ST elevation myocardial infarction and undergoing primary PCI in Assuit University Hospital.
Key exclusion criteria (1 listed)
- -Patients who present with STEMI but will not undergo primary PCI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Percutaneous Coronary InterventionPrimary PCI will be done for patients with STEMI in both groups of patients | Device | Addict patients, Non Addict patients |
Primary outcome
outcome of primary PCI in addict STEMI patients
Time frame: 30 minutes
Identify the in-hospital outcome of primary PCI in treatment of STEMI in addict patients in comparison to non-addict patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- .World Health Organization (2014): Global status report on noncommunicable diseases. https://en.wikipedia.org/wiki/World\_Health\_OrganizationLink provided by the sponsor.
Related trials for ST Elevation Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcome of primary PCI in addict STEMI patients (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.