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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04835974
Other study ID # No-reflow phenomenon
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date May 2022

Study information

Verified date April 2021
Source Assiut University
Contact alzahraa gamal, master
Phone 01026181748
Email alzahraagamal@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

1- to find metabolic factors that correlate with the development of no reflow phenomenon that may help prevent its occurrence .


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 . .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date May 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 .

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 . baseline
Secondary 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 baseline
Secondary measure the lipid profile to detect the correlation between lipid profile and no-reflow phenomenon baseline
See also
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Completed NCT04785209 - Mean Platelet Volume and STEMI Clinical Risk Scores in Prediction of Impaired Myocardial Perfusion In Acute STEMI Patients Undergoing Primary Percutaneous Coronary Intervention.
Not yet recruiting NCT06342141 - Empagliflozin for No-reflow Phenomenon in PCI for STEMI Phase 2
Not yet recruiting NCT05360602 - Alpha Lipoic Acid Effect on No-Reflow Phenomenon N/A
Completed NCT02054000 - Intracoronary Tirofiban on No-Reflow Phenomena Phase 4
Not yet recruiting NCT05393557 - Upfront Premedication For Reduction of Microvascular Obstruction and No-reflow in Treating ST-segment Elevation Myocardial Infarction N/A
Completed NCT04699110 - Adrenaline for the Treatment of No-Reflow in Normotensive Patients Phase 4
Completed NCT04573751 - The EPIVER Randomized Controlled Trial N/A
Not yet recruiting NCT02233790 - Ticagrelor and Clopidogrel on Reperfusion in Patients With AMI Phase 4
Recruiting NCT05427786 - A Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT reductioN Of decREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease Phase 4
Completed NCT05355532 - Genetic Determinants of the Coronary Microvascular Obstruction in PCI