Impact of Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
NCT ID: NCT04651842
Last Updated: 2020-12-03
Study Results
Results pending
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Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
240 participants
Study Classification
OBSERVATIONAL
Study Start Date
2018-05-01
Study Completion Date
2019-05-01
Brief Summary
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Full myocardial reperfusion with restoration of coronary microcirculatory function (CMF) is a therapeutic goal in ST-segment elevation myocardial infarction (STEMI).1 Despite the success of primary percutaneous coronary intervention (pPCI), it is not achieved in 30% to 50% of patients.2,3 Insulin resistance (IR) as a part of metabolic syndrome is an important risk factor for the development of cardiac and vascular impairments and carries ominous prognosis in the setting of acute myocardial infarction.4 As a part of metabolic syndrome, IR is associated with myocardial and microvascular injury after STEMI in clinical studies. As phenomenon per se, independent of other components of metabolic syndrome, IR was related to ischemic myocardial injury after elective PCI.5
Recently, IR in the early phase of acute coronary syndrome in non-diabetic patients, assessed by the homeostatic model assessment (HOMA) index, was established as an independent predictor of in-hospital mortality. This "acute" IR is a part of the acute glycometabolic response to stress, can be transient and can occur even in patients without chronic glycometabolic derangements.6
Acute IR comprises acute hyperglycemia and/or acute hyperinsulinemia; Hyperglycemia has the prognostic relevance of hyperinsulinemia in STEMI patients and its relationship with coronary flow are less well evaluated.it also acknowledged direct acute negative cardiovascular effects as it is contributing to incomplete myocardial reperfusion and CMF impairment. The prognostic relevance of hyperinsulinemia in STEMI patients and its relationship with coronary flow are less well evaluated and acknowledged.7,8 Myocardial blush was first defined by Arnoud van't Hof etal . It is a qualitative visual assessment of the amount of contrast medium filling a territory supplied by a pericardial coronary artery.9 Myocardial blush grade is a valuable tool for assessing coronary microvasculature and myocardial perfusion in patients undergoing coronary angiography and angioplasty.
Reduced myocardial blush grade identifies patients at higher risk who need more aggressive treatment both during the procedure to improve myocardial perfusion and later for secondary prevention.10
We postulate that IR can occur in the early post pPCI period as a dynamic phenomenon even in non-diabetic patients, and be related to the development of microvascular injury. We have defined myocardial blush as a marker of coronary microvascular function, Accordingly, we have evaluated IR in relation to myocardial blush in non-diabetic STEMI patients treated by pPCI. as a primary end-point. The residual ST-segment elevation, post-TFC%; and MACE were secondary end points. The HOMA index is a simple and inexpensive marker of IR primary used in chronic states. It was recently validated against euglycemic hyperinsulinemic clamp in STEMI patients as feasible for assessing IR during myocardial infarction and therefore used in the current study.11
Recently, IR in the early phase of acute coronary syndrome in non-diabetic patients, assessed by the homeostatic model assessment (HOMA) index, was established as an independent predictor of in-hospital mortality. This "acute" IR is a part of the acute glycometabolic response to stress, can be transient and can occur even in patients without chronic glycometabolic derangements.6
Acute IR comprises acute hyperglycemia and/or acute hyperinsulinemia; Hyperglycemia has the prognostic relevance of hyperinsulinemia in STEMI patients and its relationship with coronary flow are less well evaluated.it also acknowledged direct acute negative cardiovascular effects as it is contributing to incomplete myocardial reperfusion and CMF impairment. The prognostic relevance of hyperinsulinemia in STEMI patients and its relationship with coronary flow are less well evaluated and acknowledged.7,8 Myocardial blush was first defined by Arnoud van't Hof etal . It is a qualitative visual assessment of the amount of contrast medium filling a territory supplied by a pericardial coronary artery.9 Myocardial blush grade is a valuable tool for assessing coronary microvasculature and myocardial perfusion in patients undergoing coronary angiography and angioplasty.
Reduced myocardial blush grade identifies patients at higher risk who need more aggressive treatment both during the procedure to improve myocardial perfusion and later for secondary prevention.10
We postulate that IR can occur in the early post pPCI period as a dynamic phenomenon even in non-diabetic patients, and be related to the development of microvascular injury. We have defined myocardial blush as a marker of coronary microvascular function, Accordingly, we have evaluated IR in relation to myocardial blush in non-diabetic STEMI patients treated by pPCI. as a primary end-point. The residual ST-segment elevation, post-TFC%; and MACE were secondary end points. The HOMA index is a simple and inexpensive marker of IR primary used in chronic states. It was recently validated against euglycemic hyperinsulinemic clamp in STEMI patients as feasible for assessing IR during myocardial infarction and therefore used in the current study.11
Detailed Description
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Myocardial blush grade is valuable tool for assessing coronary microvasculature and myocardial perfusion in patients undergoing coronary angiography and angioplasty and its reduction identifies patients at high risk. In this study we investigate the association of acute insulin resistance with myocardial blush grade and outcome in non-diabetic patients with ST-segment elevation myocardial infarction (STEMI).
Conditions
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Insulin Resistance and PCI
Study Design
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Observational Model Type
OTHER
Study Time Perspective
CROSS_SECTIONAL
Study Groups
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HOMA IR high
classified based on equal tertile of HOMA IR level into 3 equal groups ( high\>6.6)
PCI
Intervention Type
DEVICE
Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
HOMA IR intermediate
classified based on equal tertile of HOMA IR level into 3 equal groups ( intermediate 4.6-6.6, )
PCI
Intervention Type
DEVICE
Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
HOMA IR low
classified based on equal tertile of HOMA IR level into 3 equal groups (low ≤ 4.6, )
PCI
Intervention Type
DEVICE
Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
Interventions
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PCI
Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
Intervention Type
DEVICE
Other Intervention Names
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primary Insulin resistance
Eligibility Criteria
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Inclusion Criteria
* This cross-sectional comparative study included 240 non-diabetic patients with acute STEMI of both sexes and different ages selected from cardiology department in Assiut University Hospital who underwent primary percutaneous coronary intervention (PCI) between first of May 2018 and first of May 2019.
Exclusion Criteria
* Patients were excluded from this study if they had diabetes mellitus; renal insufficiency (creatinine \>2 mg/dl); advanced hepatic dysfunction; taken anti-oxidant supplement/therapy within the past 4 weeks before enrollment; pregnant; were alcoholic; had allergy to radiographic contrast; uncooperative patient or patient refusal; also if they had malignancy; chronic heart failure or cardiomyopathy; prior myocardial infarction and diseases requiring steroid therapy
Minimum Eligible Age
50 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Assiut University
OTHER
Sponsor Role
lead
Responsible Party
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Soher Moustafa Kasem
Prof
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Faculty of Medicine
Asyut, , Egypt
Site Status
Countries
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Egypt
References
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Lerman A, Holmes DR, Herrmann J, Gersh BJ. Microcirculatory dysfunction in ST-elevation myocardial infarction: cause, consequence, or both? Eur Heart J. 2007 Apr;28(7):788-97. doi: 10.1093/eurheartj/ehl501. Epub 2007 Mar 8.
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Arnold SV, Lipska KJ, Li Y, Goyal A, Maddox TM, McGuire DK, Spertus JA, Kosiborod M. The reliability and prognosis of in-hospital diagnosis of metabolic syndrome in the setting of acute myocardial infarction. J Am Coll Cardiol. 2013 Aug 20;62(8):704-8. doi: 10.1016/j.jacc.2013.02.062. Epub 2013 Apr 3.
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BACKGROUND
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Sanjuan R, Blasco ML, Huerta R, Palacios L, Carratala A, Nunyez J, Sanchis J. Insulin resistance and short-term mortality in patients with acute myocardial infarction. Int J Cardiol. 2014 Mar 15;172(2):e269-70. doi: 10.1016/j.ijcard.2013.12.207. Epub 2014 Jan 8. No abstract available.
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Zarich SW, Nesto RW. Implications and treatment of acute hyperglycemia in the setting of acute myocardial infarction. Circulation. 2007 May 8;115(18):e436-9. doi: 10.1161/CIRCULATIONAHA.105.535732. No abstract available.
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BACKGROUND
van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. doi: 10.1161/01.cir.97.23.2302.
Reference Type
BACKGROUND
Tsvetkov H, Mosseri M. Myocardial blush grade: an interventional method for assessing myocardial perfusion. Isr Med Assoc J. 2008 Jun;10(6):465-7. No abstract available.
Reference Type
BACKGROUND
Moura FA, Carvalho LS, Cintra RM, Martins NV, Figueiredo VN, Quinaglia e Silva JC, Almeida OL, Coelho OR, Sposito AC. Validation of surrogate indexes of insulin sensitivity in acute phase of myocardial infarction based on euglycemic-hyperinsulinemic clamp. Am J Physiol Endocrinol Metab. 2014 Feb 15;306(4):E399-403. doi: 10.1152/ajpendo.00566.2013. Epub 2013 Dec 17.
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American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.
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Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, Stone NJ; Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. J Am Coll Cardiol. 2004 Aug 4;44(3):720-32. doi: 10.1016/j.jacc.2004.07.001.
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de Boer MJ, Reiber JH, Suryapranata H, van den Brand MJ, Hoorntje JC, Zijlstra F. Angiographic findings and catheterization laboratory events in patients with primary coronary angioplasty or streptokinase therapy for acute myocardial infarction. Eur Heart J. 1995 Oct;16(10):1347-55. doi: 10.1093/oxfordjournals.eurheartj.a060741.
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Kasem SM, Saied GM, Hegazy ANM, Abdelsabour M. Impact of Acute Insulin Resistance on Myocardial Blush in Non-Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention. Front Cardiovasc Med. 2021 May 10;8:647366. doi: 10.3389/fcvm.2021.647366. eCollection 2021.
Reference Type
DERIVED
Other Identifiers
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Insulin resistance and PCI
Identifier Type: -
Identifier Source: org_study_id