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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03164707
Other study ID # Serum Blood Glucose Level
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 22, 2017
Last updated May 22, 2017
Start date December 1, 2017
Est. completion date June 1, 2019

Study information

Verified date May 2017
Source Assiut University
Contact Amr Ahmed Yousef, Professor
Phone 01006554042
Email Amryoussef111@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 1, 2019
Est. primary completion date December 1, 2018
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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).

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood Glucose Level
ON Admission Blood Glucose Level Fasting Blood Glucose Level

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & 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 myocard — View Citation

Gearhart MM, Parbhoo SK. Hyperglycemia in the critically ill patient. AACN Clin Issues. 2006 Jan-Mar;17(1):50-5. Review. — View Citation

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 — View Citation

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 myocardi — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of level of blood glucose on admission in patients with ST Segment Elevation Myocardial Infarction and Hospital Outcome 1 month