Impact of Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention

Completed

• Conditions: Insulin Resistance and PCI
• Interventions: Device: PCI

• Registration Number: NCT04651842
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Last Update Submitted: 2020-11-26
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HOMA IR high	PCI	classified based on equal tertile of HOMA IR level into 3 equal groups ( high\>6.6)
HOMA IR intermediate	PCI	classified based on equal tertile of HOMA IR level into 3 equal groups ( intermediate 4.6-6.6, )
HOMA IR low	PCI	classified based on equal tertile of HOMA IR level into 3 equal groups (low ≤ 4.6, )

Primary Outcome Measures

Name	Time	Method
arrythmia,LVF,Pulmonary edema,Cardiogenic shock, In hospital re-infarction,In hospital stent thrombosis	May2018 to May 2019

Secondary Outcome Measures

Name	Time	Method
In hospial mortality	May 2018 to May2019

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt