Procedure and In-hospital Outcome of Patients Under 40 Years Old Undergoing Primary Percutaneous Coronary Intervention for Acute ST Elevated Myocardial Infarction in Assiut University

August 28, 2017 updated by: mohamed taha galal, Assiut University
Sample size of 117 patients presented with ST elevated myocardial infarction for PPCI starting from september 2017 will be divided to 2 groups, group 1 age up to 40 years old and group 2 older than 40 years then previous history and clinical data and angiographic data at PPCI and follow up in-hospital and after discharge for 3 months all these data will be compared at both groups.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Myocardial infarction (MI) is a disease of middle and advanced age.

Most of the present knowledge of infarction is derived from studies in this older cohort of patients.

In fact, some clinical studies of patients with chest pain have excluded individuals under 40 years of age

Although thrombolytic therapy has been shown to improve survival in elderly AMI patients when compared with placebo, many studies have shown lower mortality rates when these patients are treated with primary percutaneous coronary intervention(PPCI) for AMI

Young adults are a relatively small portion of those having acute myocardial infarction (AMI). However they are an important group to examine with regard to risk factor modification and secondary prevention.

Previous studies have estimated that young patients of less than 40 years old make up between 2% and 6% of all AMI

young patients has different characteristics from that in the older coronary arteriography performed in young patients after myocardial infarction has identified a relatively high prevalence of angiographically normal coronary arteries.

Risk factor analysis in young AMI patients has revealed a high prevalence of current smoking, hyperlipidemia and positive family history

In addition, non-classical risk factors such as vasospastic tendencies, thrombophilic conditions and a history of Kawasaki disease have also been proposed as the causes of AMI in young patients.

PPCI is now widely accepted as a therapeutic strategy for older patients with AMI. Early, complete revascularization can salvage myocardium at risk and improve survival rates.

However on the basis of the difference in etiology of AMI, there is a possibility that the clinical effectiveness of PCI for young adults with AMI might be different from that old patients

Nevertheless, coronary artery disease has been recognized in young age groups more frequently in recent years.

It is a topic of increasing clinical interest due to the potential for premature death and long-term disability.

Aim of the study :

The purpose of the present study is to examine the clinical background, angiographic findings, acute results and in-hospital outcome of PPCI in young adults with AMI (less than 40 years) compared with those non young group (more than 40 years) .

Type of the study: case only , prospective study .Study Setting: cardiology department , assuit university hospital , assuit , Egypt

Study subjects:

  1. Inclusion criteria:

    All patients with acute myocardial infarction (STEMI) : chest pain > 30 minutes and ST segment elevation in more than one lead , treated with PPCI at assuit university hospital starting from September 2017 .

  2. Exclusion criteria:

    Patients undergoing elective percutaneous intervention and thrombolytic therapy.

  3. Sample Size Calculation: : Sample size was calculated using Epi-info version 3 , based on previous studies , prevalence of MI in Egypt is 8.3 % , with confident level of 95 % , the sample needed for the study was estimated to be about 117

Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):

All patient will be subjected to :

1-history taking , clinical examination & assessment of clinical risk factors of coronary heart disease as ( age , sex , family history ,DM , HTN ,smoking , addiction and type of addiction , previous ACS ,previous PCI , psychic trauma ,history of chest obstructive , renal and vascular disease , weight ,length ,BMI ,BSA , obesity , KILLIP class , ischemic time , preinfarction angina ,mode of transport 2-12 lead ECG before and after PPCI. 3-Angiongraphic findings, acute results of PPCI ( previous PCI , culprit artery , if MVD , which segment affected ,presence or absence of visible thrombus ,type of penetrating wire ,direct stenting or not ,type of the stent , name of the stent , number of stents , diameter and length of each stent , usage of thrombus aspiration , balloon dilatation ,diameter and length of the balloon ,and inflation pressure ,volume of contrast ,final TIMI flow ,presence of collaterals.

4-evaluation of PCI success (in-hospital):

a-angiographic success :( residual stenosis ≤ 30% and TIMI flow grade 3) and side branch angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3)

a- procedural success : achievement of angiographic success without major clinical complication as ( death ,MI ,emergency coronary artery bypass surgery ) during hospitalization .

c- clinical success : in the short term , recovering of signs and symptoms of myocardial ischemia .

5-Therapuetic data as ( aspirin loading dose , clopidogrel loading dose ,maintenance dose and its duration , ticagrelor loading dose ,maintenance dose and its duration , usage of tirofiban intracoronary or intravenous ) 6- echocardiographic finding during admission ( EF by Simpson and M-mode , SWMA, mechanical complication ) 7-laboratory finding during admission ( total cholesterol , LDL , HDL , TG , basal creatinine , creatinine at discharge ,basal CK and CKMB , peak CK and CKMB , CK - CKMB - TNL at discharge , hemoglobin and platelet level ) 8-follow up after 3 months for ( mortality , ACS, MI , target artery revascularization ,ISR ,HF ,follow up echo EF by Simpson and M-mode , SWMA )

Study Type

Observational

Enrollment (Anticipated)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut university hospitals
        • Contact:
        • Principal Investigator:
          • Salwa R Dimitry, MD
        • Sub-Investigator:
          • Mohamed A Farghal, MD
        • Sub-Investigator:
          • Mohamed A Abdelhafez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with acute myocardial infarction who receive treatment at Assiut University Hospitals in the acute setting.

Description

Inclusion Criteria:

  • All patients with acute myocardial infarction (STEMI): chest pain > 30 minutes and ST segment elevation in more than one lead, treated with PPCI at Assiut University Hospitals starting from September 2017.

Exclusion Criteria:

  • Patients undergoing elective percutaneous intervention and thrombolytic therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
ST elevated myocardial infarction patient presented to assiut university hospital for Primary Percutaneous Coronary Intervention (PPCI) and their age is up to 40 years old
Procedure: Primary Percutaneous Coronary Intervention (PPCI)
Percutaneous Coronary Intervention in patients of acute myocardial infarction diagnosed using ECG findings
group 2
ST elevated myocardial infarction patient presented to assiut university hospital for Primary Percutaneous Coronary Intervention (PPCI) and their age is more than 40 years old
Procedure: Primary Percutaneous Coronary Intervention (PPCI)
Percutaneous Coronary Intervention in patients of acute myocardial infarction diagnosed using ECG findings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical outcome
Time Frame: 48 hours

Evaluation of PCI success (in-hospital):

  1. angiographic success: (residual stenosis ≤ 30% and TIMI flow grade 3) and side branch angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3) am
  2. procedural success: achievement of angiographic success without major clinical complication as (death, MI,emergency coronary artery bypass surgery) during hospitalization.
  3. clinical success: in the short term, recovering of signs and symptoms of myocardial ischemia.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (Actual)

August 30, 2017

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17100289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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