NCT04835974

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Status
unknown

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

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

March 23, 2021

Last Update Submit

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

EXPERIMENTAL

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.

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

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

diabetic patients with reflow phenomenon

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

No-Reflow Phenomenon

Condition Hierarchy (Ancestors)

IschemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

alzahraa gamal, master

CONTACT

hatem abdel elrahman

CONTACT

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