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the No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI)

Primary Purpose

No-Reflow Phenomenon

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for No-Reflow Phenomenon

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diabetic patients with STEMI treated with primary PCI

Exclusion Criteria:

non diabetic . with selected PCI

  • (1) a history of an unprotected left main artery with severe liver and kidney diseases or coronary artery bypass grafting .

    (2) patients who had valvular disease or cardiomyopathy . (3) severe dissection, thromboembolism in other parts, or vasospasm; and known malignancy .

    (4) patients with contraindications for anticoagulant therapy, such as active visceral hemorrhage, hemorrhagic stroke, or ischemic stroke within half a year (including transient ischemic attack), or aortic dissection, or patients with hematological diseases complicated with coagulation disorders .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    diabetic patients with reflow phenomenon

    Arm Description

    All Assiut University heart Hospital patients ,and who meet the listed inclusion and exclusion criteria will be eligible for the study. Patients' charts will be retrieved based on their intervention procedures. The charts will be reviewed and eligible patients will be filtered. The needed variables will be entered into our data base for later data analysis.

    Outcomes

    Primary Outcome Measures

    measure serum random blood sugar
    to detect the correlation between the diabetus mellitus (serum random blood sugar) and no-reflow phenomenon and analysis of this metabolic factors in patient withSTEMI who will undergo primaru PCI and show its effects on no-reflow phenomenon that may help prevent its occurrence .

    Secondary Outcome Measures

    measure the serum uric acid
    to detect the correlation between the serum uric acid , lipid profile and no-reflow phenomenon and show other metabolic factors effects on no-reflow to avoid its occurance
    measure the lipid profile
    to detect the correlation between lipid profile and no-reflow phenomenon

    Full Information

    First Posted
    March 23, 2021
    Last Updated
    April 13, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04835974
    Brief Title
    the No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI)
    Official Title
    Metabolic Profile as a Predictor of No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2021 (Anticipated)
    Primary Completion Date
    May 1, 2022 (Anticipated)
    Study Completion Date
    May 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    1- to find metabolic factors that correlate with the development of no reflow phenomenon that may help prevent its occurrence .
    Detailed Description
    Acute myocardial infarction (AMI) with its accompanying adverse sequelae is one of the most common causes of morbidity and mortality in the world . Although reperfusion techniques for ST- elevation myocardial infarction (STEMI ) are constantly improving, no-reflow can still lead to poor prognosis . At present, the exact mechanism of no-reflow remains unclear, but clinical and laboratory findings suggest that it is related to the embolism of the capillary bed, ischemic injury, vascular endothelial dysfunction, production of oxygen free radical , and other factors . The no-reflow phenomenon is one of complications of poor functional and clinical outcomes for patients with (AMI) . The no-reflow phenomenon is present in 25% to 30% of patients with (AMI) underwent successful coronary recanalization, as shown by angiography . The myocardial no-reflow phenomenon is associated with a reducution of antegrade myocardial blood flow inspite of an open infarct-related artery in patients with (STEMI ) undergoing (PCI). Importantly, no-reflow is known to be related to unfavorable clinical outcome and prognosis . The cause of this complex phenomenon is the variable combination of four pathogenetic components: distal atherothrombotic embolization, ischemic injury, reperfusion injury and susceptibility of coronary microcirculation to injury . As a consequence, appropriate strategies are expected to prevent or treat these components are expected to avoid the no-reflow. Coronary reperfusion therapy is widely performed in patients with (AMI) . However, in spite of patency of the infarct-related artery , there is no guarantee of salvage of myocardium at risk of ischemia .The no-reflow phenomenon is found in >30% of patients after thrombolysis or catheter-based (PCI) for (AMI) . It is important, therefore, to be able to predict which lesions are high risk for no reflow before beginning PCI . There are numerous recognized risk factors for the development of coronary artery disease (CAD), one of the best known is the association between blood lipids and CAD . Several prospective studies have established that the risk of cardiac morbidity and mortality is directly related to the concentration of plasma cholesterol. ' The most prevalent view is that the increased risk of myocardial infarction associated with elevated plasma cholesterol levels can be adequately explained on the basis of the increase in number and severity of coronary atherosclerotic vascular lesions . .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    No-Reflow Phenomenon

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    diabetic patients with reflow phenomenon
    Arm Type
    Experimental
    Arm Description
    All Assiut University heart Hospital patients ,and who meet the listed inclusion and exclusion criteria will be eligible for the study. Patients' charts will be retrieved based on their intervention procedures. The charts will be reviewed and eligible patients will be filtered. The needed variables will be entered into our data base for later data analysis.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S
    Intervention Description
    Blood samples were obtained before PCI, and the following parameters will be measured: LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. Glycemia will be assessed : RBS ( random blood sugar ) . Serum Uric acid : S .UA
    Primary Outcome Measure Information:
    Title
    measure serum random blood sugar
    Description
    to detect the correlation between the diabetus mellitus (serum random blood sugar) and no-reflow phenomenon and analysis of this metabolic factors in patient withSTEMI who will undergo primaru PCI and show its effects on no-reflow phenomenon that may help prevent its occurrence .
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    measure the serum uric acid
    Description
    to detect the correlation between the serum uric acid , lipid profile and no-reflow phenomenon and show other metabolic factors effects on no-reflow to avoid its occurance
    Time Frame
    baseline
    Title
    measure the lipid profile
    Description
    to detect the correlation between lipid profile and no-reflow phenomenon
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: diabetic patients with STEMI treated with primary PCI Exclusion Criteria: non diabetic . with selected PCI (1) a history of an unprotected left main artery with severe liver and kidney diseases or coronary artery bypass grafting . (2) patients who had valvular disease or cardiomyopathy . (3) severe dissection, thromboembolism in other parts, or vasospasm; and known malignancy . (4) patients with contraindications for anticoagulant therapy, such as active visceral hemorrhage, hemorrhagic stroke, or ischemic stroke within half a year (including transient ischemic attack), or aortic dissection, or patients with hematological diseases complicated with coagulation disorders .
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    alzahraa gamal, master
    Phone
    01026181748
    Email
    alzahraagamal@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    hatem abdel elrahman
    Phone
    01005212162
    Email
    Hatem19652006@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    6683937
    Citation
    Bernstein JM, Lee J, Conboy K, Ellis E, Li P. The role of IgE mediated hypersensitivity in recurrent otitis media with effusion. Am J Otol. 1983 Jul;5(1):66-9. No abstract available.
    Results Reference
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