NCT03164707

Brief Summary

Coronary atherosclerosis is the leading cause of death worldwide. Diabetes mellitus is associated with increased prevalence of coronary artery disease Increased plasma glucose is a common feature in the acute phase of myocardial infarction, even in patients without diabetes. Patients with stress hyperglycemia, but without previous diagnosis of diabetes, were at increased risk of congestive heart failure, arrhythmia and cardiogenic shock as well as increased both in-hospital and long-term mortality . Previous studies have demonstrated larger infarct size and poorer prognosis inpatients with hyperglycemia upon hospital admission compared with patients without hyperglycemia It has been reported that stress hyperglycemia impairs microvascular circulation and may lead to no-reflow phenomenon. No reflow phenomenon was significantly more frequent among patients with hyperglycemia and increased progressively with increasing admission blood glucose in patients with Acute Myocardial Infarction . Furthermore, patients with high admission glucose are more likely to develop restenosis and require repeat revascularization procedures compared with those with normal admission glucose and are also at increased risk for repeated Myocardial Infarction, stent thrombosis and death.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

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

May 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 22, 2017

Last Update Submit

May 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation of level of blood glucose on admission in patients with ST Segment Elevation Myocardial Infarction and Hospital Outcome

    1 month

Interventions

Blood Glucose LevelDIAGNOSTIC_TEST

ON Admission Blood Glucose Level Fasting Blood Glucose Level

Eligibility Criteria

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

Patients with Acute ST Segment Elevation Myocardial Infarction admitted in Assiut University Hospital

You may qualify if:

  • acute ST Segment Elevation Myocardial Infarction patients not known to have Diabetes Mellitus undergoing primary PCI.

You may not qualify if:

  • patients known to have Diabetes mellitus (known diabetes mellitus on admission, which was treated with diet, oral glucose-lowering medication, and/or insulin).
  • Patients with prior Primary Percutaneous Intervention and/or Coronary Artery Bypass Graft (altering disease state).
  • Patients with severe liver or renal disease (altering disease state).
  • Patients with anemia, kidney disease or certain blood disorders (thalassemia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Cura FA, L'Allier PL, Kapadia SR, Houghtaling PL, Dipaola LM, Ellis SG, Topol EJ, Brener SJ; GUSTO IIb and RAPPORT Investigators. Predictors and prognosis of suboptimal coronary blood flow after primary coronary angioplasty in patients with acute myocardial infarction. Am J Cardiol. 2001 Jul 15;88(2):124-8. doi: 10.1016/s0002-9149(01)01605-8.

  • Gearhart MM, Parbhoo SK. Hyperglycemia in the critically ill patient. AACN Clin Issues. 2006 Jan-Mar;17(1):50-5. doi: 10.1097/00044067-200601000-00007.

  • Iwakura K, Ito H, Ikushima M, Kawano S, Okamura A, Asano K, Kuroda T, Tanaka K, Masuyama T, Hori M, Fujii K. Association between hyperglycemia and the no-reflow phenomenon in patients with acute myocardial infarction. J Am Coll Cardiol. 2003 Jan 1;41(1):1-7. doi: 10.1016/s0735-1097(02)02626-8.

  • Mehta RH, Harjai KJ, Cox D, Stone GW, Brodie B, Boura J, O'Neill W, Grines CL; Primary Angioplasty in Myocardial Infarction (PAMI) Investigators. Clinical and angiographic correlates and outcomes of suboptimal coronary flow inpatients with acute myocardial infarction undergoing primary percutaneous coronary intervention. J Am Coll Cardiol. 2003 Nov 19;42(10):1739-46. doi: 10.1016/j.jacc.2003.07.012.

  • Rasoul S, Ottervanger JP, Bilo HJ, Timmer JR, van 't Hof AW, Dambrink JH, Dikkeschei LD, Hoorntje JC, de Boer MJ, Zijlstra F. Glucose dysregulation in nondiabetic patients with ST-elevation myocardial infarction: acute and chronic glucose dysregulation in STEMI. Neth J Med. 2007 Mar;65(3):95-100.

Study Officials

  • George Motea Doos, M.B.B.CH

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr Ahmed Yousef, Professor

CONTACT

Heba Mahmoud Elnaggar, Lecturer

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 24, 2017

Study Start

December 1, 2017

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

May 24, 2017

Record last verified: 2017-05