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ST Elevation Myocardial InfarctionNCT03266328

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

An observational study of ST Elevation Myocardial Infarction, run by Assiut University at 1 site in Egypt.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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… 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 (PPCI)
Type of treatment
Surgery or procedure
How many people
117 participants
Where
1 siteEgypt
Study dates
1 Sep 2017to 1 Aug 2018
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: Patients with acute myocardial infarction who receive treatment at Assiut University Hospitals in the acute setting.

Who may be able to join

  • 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.

Who cannot join

  • Patients undergoing elective percutaneous intervention and thrombolytic therapy.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Assiut University Hospitals

    Asyut, 71515

    Mohamed T Galal, MBBCh, mohamedtahagalal@yahoo.com

    Salwa R Dimitry, MD

Other trials in Egypt

About this study

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.

Read the 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 )

Being tested
Primary Percutaneous Coronary Intervention (PPCI)
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 Intervention (PPCI)Procedure or surgery

    Percutaneous Coronary Intervention in patients of acute myocardial infarction diagnosed using ECG findings

Study groups in NCT03266328
Study groupRoleWhat they receive
group 1ST elevated myocardial infarction patient presented to assiut university hospital for Primary Percutaneous Coronary Intervention (PPCI) and their age is up to 40 years old
Receives: Procedure: Primary Percutaneous Coronary Intervention (PPCI)
group 2ST elevated myocardial infarction patient presented to assiut university hospital for Primary Percutaneous Coronary Intervention (PPCI) and their age is more than 40 years old
Receives: Procedure: Primary Percutaneous Coronary Intervention (PPCI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinical outcome

    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.

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2017
  2. Study start1 Sep 2017 (estimated)
  3. Primary completion1 Jul 2018 (estimated)
  4. Study completion1 Aug 2018 (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
117 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03266328
Sponsor's protocol ID
17100289
Status last verified
Aug 2017
First submitted
24 Aug 2017
Last updated
30 Aug 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee TH, Cook EF, Weisberg M, Sargent RK, Wilson C, Goldman L. Acute chest pain in the emergency room. Identification and examination of low-risk patients. Arch Intern Med. 1985 Jan;145(1):65-9.

    PubMed 3970650
  • Pozen MW, D'Agostino RB, Selker HP, Sytkowski PA, Hood WB Jr. A predictive instrument to improve coronary-care-unit admission practices in acute ischemic heart disease. A prospective multicenter clinical trial. N Engl J Med. 1984 May 17;310(20):1273-8. doi: 10.1056/NEJM198405173102001.

    PubMed 6371525
  • Towbin JA, Bricker JT, Garson A Jr. Electrocardiographic criteria for diagnosis of acute myocardial infarction in childhood. Am J Cardiol. 1992 Jun 15;69(19):1545-8. doi: 10.1016/0002-9149(92)90700-9.

    PubMed 1598867
  • Weinberger I, Rotenberg Z, Fuchs J, Sagy A, Friedmann J, Agmon J. Myocardial infarction in young adults under 30 years: risk factors and clinical course. Clin Cardiol. 1987 Jan;10(1):9-15. doi: 10.1002/clc.4960100104.

    PubMed 3815921
  • Chouhan L, Hajar HA, Pomposiello JC. Comparison of thrombolytic therapy for acute myocardial infarction in patients aged < 35 and > 55 years. Am J Cardiol. 1993 Jan 15;71(2):157-9. doi: 10.1016/0002-9149(93)90731-q.

    PubMed 8421976
  • Perski A, Olsson G, Landou C, de Faire U, Theorell T, Hamsten A. Minimum heart rate and coronary atherosclerosis: independent relations to global severity and rate of progression of angiographic lesions in men with myocardial infarction at a young age. Am Heart J. 1992 Mar;123(3):609-16. doi: 10.1016/0002-8703(92)90497-j.

    PubMed 1539512
  • Weaver WD, Litwin PE, Martin JS, Kudenchuk PJ, Maynard C, Eisenberg MS, Ho MT, Cobb LA, Kennedy JW, Wirkus MS. Effect of age on use of thrombolytic therapy and mortality in acute myocardial infarction. The MITI Project Group. J Am Coll Cardiol. 1991 Sep;18(3):657-62. doi: 10.1016/0735-1097(91)90784-7.

    PubMed 1869726
  • Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb) Angioplasty Substudy Investigators. A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction. N Engl J Med. 1997 Jun 5;336(23):1621-8. doi: 10.1056/NEJM199706053362301.

    PubMed 9173270
  • Zimmerman FH, Cameron A, Fisher LD, Ng G. Myocardial infarction in young adults: angiographic characterization, risk factors and prognosis (Coronary Artery Surgery Study Registry). J Am Coll Cardiol. 1995 Sep;26(3):654-61. doi: 10.1016/0735-1097(95)00254-2.

    PubMed 7642855
  • Fournier JA, Sanchez A, Quero J, Fernandez-Cortacero JA, Gonzalez-Barrero A. Myocardial infarction in men aged 40 years or less: a prospective clinical-angiographic study. Clin Cardiol. 1996 Aug;19(8):631-6. doi: 10.1002/clc.4960190809.

    PubMed 8864336
  • Imazio M, Bobbio M, Bergerone S, Barlera S, Maggioni AP. Clinical and epidemiological characteristics of juvenile myocardial infarction in Italy: the GISSI experience. G Ital Cardiol. 1998 May;28(5):505-12.

    PubMed 9646064
  • Kannel WB, Abbott RD. Incidence and prognosis of unrecognized myocardial infarction. An update on the Framingham study. N Engl J Med. 1984 Nov 1;311(18):1144-7. doi: 10.1056/NEJM198411013111802.

    PubMed 6482932
  • Warren SE, Thompson SI, Vieweg WV. Historic and angiographic features of young adults surviving myocardial infarction. Chest. 1979 Jun;75(6):667-70. doi: 10.1378/chest.75.6.667.

    PubMed 436516
  • Wolfe MW, Vacek JL. Myocardial infarction in the young. Angiographic features and risk factor analysis of patients with myocardial infarction at or before the age of 35 years. Chest. 1988 Nov;94(5):926-30. doi: 10.1378/chest.94.5.926.

    PubMed 3180896
  • Davia JE, Hallal FJ, Cheitlin MD, Gregoratos G, McCarty R, Foote W. Coronary artery disease in young patients: arteriographic and clinical review of 40 cases aged 35 and under. Am Heart J. 1974 Jun;87(6):689-96. doi: 10.1016/0002-8703(74)90412-8. No abstract available.

    PubMed 4828802

Questions about this trial

What is this clinical trial studying?

An observational study of ST Elevation Myocardial Infarction, run by Assiut University at 1 site in Egypt.

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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical outcome (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03266328, which also lists 34 linked publications.

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 30 Aug 2017.

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