Predictive Value of Admission Blood Glucose Level in Acute Myocardial InfarctionNCT03164707
Predictive Value Of Admission Blood Glucose Level In Patients With Acute Myocardial Infarction
An observational study of Predictive Value of Admission Blood Glucose Level in Acute Myocardial Infarction, run by Assiut University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Predictive Value of Admission Blood Glucose Level in Acute Myocardial Infarction
- What is being tested?
- Blood Glucose Level
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Jun 2019
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with Acute ST Segment Elevation Myocardial Infarction admitted in Assiut University Hospital
Who may be able to join
- acute ST Segment Elevation Myocardial Infarction patients not known to have Diabetes Mellitus undergoing primary PCI.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Predictive ValueOf Admission Blood Glucose Level In Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Angioplasty
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.
- Being tested
- Blood Glucose Level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Glucose LevelDiagnostic test
ON Admission Blood Glucose Level Fasting Blood Glucose Level
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of level of blood glucose on admission in patients with ST Segment Elevation Myocardial Infarction and Hospital Outcome
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Predictive Value of Admission Blood Glucose Level in Acute 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Motea Ghayes, Assiut University
- Investigators
- George Motea Doos, M.B.B.CH, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164707
- Sponsor's protocol ID
- Serum Blood Glucose Level
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11448407Gearhart 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.
PubMed 16462409Iwakura 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.
PubMed 12570936Mehta 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.
PubMed 14642681Rasoul 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.
PubMed 17387235
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive ValueOf Admission Blood Glucose Level In Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Angioplasty
- ClinicalTrials.gov ID
- NCT03164707
- Acronym / sponsor ID
- Serum Blood Glucose Level
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 24 May 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Acute ST Segment Elevation Myocardial Infarction admitted in Assiut University Hospital
Key inclusion criteria (1 listed)
- acute ST Segment Elevation Myocardial Infarction patients not known to have Diabetes Mellitus undergoing primary PCI.
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| Blood Glucose LevelON Admission Blood Glucose Level Fasting Blood Glucose Level | Diagnostic test | – |
Primary outcome
Correlation of level of blood glucose on admission in patients with ST Segment Elevation Myocardial Infarction and Hospital Outcome
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Results publication: PubMed 11448407Cura 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.
- Results publication: PubMed 16462409Gearhart 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.
- Results publication: PubMed 12570936Iwakura 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.
- Results publication: PubMed 14642681Mehta 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.
- Results publication: PubMed 17387235Rasoul 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.
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.
George Motea Doos, M.B.B.CH principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Predictive Value of Admission Blood Glucose Level in Acute Myocardial Infarction, run by Assiut University.
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 4 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 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Amr Ahmed Yousef, Professor (01006554042 ext. +2, Amryoussef111@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of level of blood glucose on admission in patients with ST Segment Elevation Myocardial Infarction and Hospital Outcome (time frame: 1 month). 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 NCT03164707, which also lists 5 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 24 May 2017.