NCT04090216

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 12, 2019

Last Update Submit

September 12, 2019

Conditions

Outcome Measures

Primary Outcomes (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.

    30 minutes

Study Arms (2)

Addict patients

patients with substance use disorders presented with STEMI \& undergoing Primary PCI

Device: Primary Percutaneous Coronary Intervention

Non Addict patients

patients without substance use disorders presented with STEMI \& undergoing Primary PCI

Device: Primary Percutaneous Coronary Intervention

Interventions

Primary PCI will be done for patients with STEMI in both groups of patients

Addict patientsNon Addict patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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 .

You may qualify if:

  • All patients of all categories of ages who will be presented with ST elevation myocardial infarction and undergoing primary PCI in Assuit University Hospital.

You may not qualify if:

  • Patients who present with STEMI but will not undergo primary PCI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Abdalla Aly Gamal

Study Record Dates

First Submitted

September 12, 2019

First Posted

September 16, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

February 1, 2021

Last Updated

September 16, 2019

Record last verified: 2019-09