the No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI)
Metabolic Profile as a Predictor of No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI)
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
1- to find metabolic factors that correlate with the development of no reflow phenomenon that may help prevent its occurrence .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedApril 14, 2021
April 1, 2021
1 year
March 23, 2021
April 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
measure the serum uric acid
baseline
measure the lipid profile
baseline
Study Arms (1)
diabetic patients with reflow phenomenon
EXPERIMENTALAll 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.
Interventions
Blood samples were obtained before PCI, and the following parameters will be measured: 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. Serum Uric acid : S .UA
Eligibility Criteria
You may qualify if:
- diabetic patients with STEMI treated with primary PCI
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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. No abstract available.
PMID: 6683937BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Metabolic profile as a predictor of no reflow in diabetic patients treated with primary Percutaneous Coronary Intervention (PCI) .
Study Record Dates
First Submitted
March 23, 2021
First Posted
April 8, 2021
Study Start
May 1, 2021
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
April 14, 2021
Record last verified: 2021-04