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ST Elevation Myocardial InfarctionNCT04090216

Outcome of Primary PCI in STEMI Addict Patients

An observational study of ST Elevation Myocardial Infarction, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

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 groups in NCT04090216
Study groupRoleWhat they receive
Addict patientspatients with substance use disorders presented with STEMI \& undergoing Primary PCI
Receives: Device: Primary Percutaneous Coronary Intervention
Non Addict patientspatients 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.

  1. 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.

  1. First posted16 Sep 2019
  2. Study start1 Jan 2020 (estimated)
  3. Primary completion1 Jan 2021 (estimated)
  4. Study completion1 Feb 2021 (estimated)

Resources

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)
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

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.

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