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.
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
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:
- 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 .
- Exclusion criteria: Patients undergoing elective percutaneous intervention and thrombolytic therapy.
- 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 )
- Conditions
- ST Elevation Myocardial Infarction
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Primary Percutaneous Coronary Intervention (PPCI) | |
| 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 Receives: Procedure: Primary Percutaneous Coronary Intervention (PPCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcome
Evaluation of PCI success (in-hospital):
- angiographic success: (residual stenosis ≤ 30% and TIMI flow grade 3) and side branch angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3) am
- procedural success: achievement of angiographic success without major clinical complication as (death, MI,emergency coronary artery bypass surgery) during hospitalization.
- 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.
- First posted30 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- 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
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed taha galal, Assiut University
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 3970650Pozen 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 6371525Towbin 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 1598867Weinberger 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 3815921Chouhan 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 8421976Perski 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 1539512Weaver 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 1869726Global 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 9173270Zimmerman 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 7642855Fournier 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 8864336Imazio 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 9646064Kannel 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 6482932Warren 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 436516Wolfe 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 3180896Davia 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03266328
- Acronym / sponsor ID
- 17100289
- Conditions
- ST Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 30 Aug 2017 (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.
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.
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:
- 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 .
- Exclusion criteria: Patients undergoing elective percutaneous intervention and thrombolytic therapy.
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: Primary Percutaneous Coronary Intervention (PPCI)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 |
| group 2 | – | Procedure: Primary Percutaneous Coronary Intervention (PPCI)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute myocardial infarction who receive treatment at Assiut University Hospitals in the acute setting.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients undergoing elective percutaneous intervention and thrombolytic therapy.
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 Intervention (PPCI)Percutaneous Coronary Intervention in patients of acute myocardial infarction diagnosed using ECG findings | Procedure or surgery | group 1, group 2 |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Background: PubMed 3970650Lee 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.
- Background: PubMed 6371525Pozen 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.
- Background: PubMed 1598867Towbin 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.
- Background: PubMed 3815921Weinberger 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.
- Background: PubMed 8421976Chouhan 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.
- Background: PubMed 1539512Perski 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.
- Background: PubMed 1869726Weaver 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.
- Background: PubMed 9173270Global 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.
- Background: PubMed 7642855Zimmerman 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.
- Background: PubMed 8864336Fournier 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.
- Background: PubMed 9646064Imazio 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.
- Background: PubMed 6482932Kannel 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
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.