NCT03266978

Brief Summary

ST-elevation myocardial infarction is a major cause of morbidity and mortality worldwide. ST-elevation myocardial infarction damages the regional myocardium that undergoes ischemia and necrosis, resulting in impairment of both systolic and diastolic functions of the heart. Left ventricular function and myocardial infarct size both serve as the main determinants Of patients' outcome after myocardial infarction. Timely management of ST-elevation myocardial infarction, using reperfusion therapy, including fibrinolysis and primary percutaneous coronary intervention, leads to a better outcome for these patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

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

August 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

August 24, 2017

Last Update Submit

August 29, 2017

Conditions

ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Admission glucose level

    Blood glucose level on admission measured by mmol/l .

    Baseline .

Secondary Outcomes (2)

  • To evaluate left ventricular systolic function.

    Baseline and latter at 6 months follow-up.

  • To evaluate left ventricular diastolic function.

    Baseline and latter at 6 months follow-up.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients presenting to investigators Coronary Care Unit - Assiut University Heart Center with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

You may qualify if:

  • The study will be performed on acute ST-elevation myocardial infarction patients with/without history of diabetes mellitus undergoing primary percutaneous coronary intervention.

You may not qualify if:

  • Patients not treated with primary percutaneous coronary intervention.
  • Patients with prior myocardial infarction, prior primary percutaneous coronary intervention and/or coronary artery bypass graft (altering disease state).
  • Patients with cardiogenic shock (altering disease state).
  • Patients with severe liver or renal disease (altering disease state).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

Location

Related Publications (5)

  • Ertelt K, Brener SJ, Mehran R, Ben-Yehuda O, McAndrew T, Stone GW. Comparison of Outcomes and Prognosis of Patients With Versus Without Newly Diagnosed Diabetes Mellitus After Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction (the HORIZONS-AMI Study). Am J Cardiol. 2017 Jun 15;119(12):1917-1923. doi: 10.1016/j.amjcard.2017.03.016. Epub 2017 Mar 29.

    PMID: 28427734RESULT

  • Ota S, Tanimoto T, Orii M, Hirata K, Shiono Y, Shimamura K, Matsuo Y, Yamano T, Ino Y, Kitabata H, Yamaguchi T, Kubo T, Tanaka A, Imanishi T, Akasaka T. Association between hyperglycemia at admission and microvascular obstruction in patients with ST-segment elevation myocardial infarction. J Cardiol. 2015 Apr;65(4):272-7. doi: 10.1016/j.jjcc.2014.10.013. Epub 2014 Dec 19.

    PMID: 25533423RESULT

  • Iwakura K. Stress hyperglycemia and microvascular obstruction after acute myocardial infarction. J Cardiol. 2015 Apr;65(4):270-1. doi: 10.1016/j.jjcc.2014.11.012. Epub 2014 Dec 29. No abstract available.

    PMID: 25553870RESULT

  • Marfella R, Siniscalchi M, Esposito K, Sellitto A, De Fanis U, Romano C, Portoghese M, Siciliano S, Nappo F, Sasso FC, Mininni N, Cacciapuoti F, Lucivero G, Giunta R, Verza M, Giugliano D. Effects of stress hyperglycemia on acute myocardial infarction: role of inflammatory immune process in functional cardiac outcome. Diabetes Care. 2003 Nov;26(11):3129-35. doi: 10.2337/diacare.26.11.3129.

    PMID: 14578250RESULT

  • Sattur S, Sarwar B, Sacchi TJ, Brener SJ. Correlation between markers of reperfusion and mortality in ST-elevation myocardial infarction: a systematic review. J Invasive Cardiol. 2014 Nov;26(11):587-95.

    PMID: 25364000RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Amr Youssef, MD

CONTACT

00201006554042amryoussef111@yahoo.com

Mahmoud Abd Allah, MD

CONTACT

00201001202779m_abd_elsabour@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pricipal investgator

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 30, 2017

Study Start

January 1, 2018

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

August 30, 2017

Record last verified: 2017-08

Locations

EG(1)