NCT04835207

Brief Summary

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 all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 2, 2021

Last Update Submit

April 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • detection correlation between DM and no-reflow phenomenon

    measurment of random blood sugar in diabetic patients treated with primary Percutaneous Coronary Intervention ( PCI ) .and show its effects on reflow

    baseline

Secondary Outcomes (2)

  • detection correlation between other metabolic factors as serum uric acid and no-reflow phenomenon

    baseline

  • detection correlation between other metabolic factors as LDL\HDL and no-reflow phenomenon

    baseline

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- S

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

diabetic patients with STEMI treated with primary PCI

You may qualify if:

  • diabetic patients with ST- elevation myocardial infarction (STEMI ) treated with primary Percutaneous Coronary Intervention ( PCI ) .

You may not qualify if:

  • diabetic patients with ST- elevation myocardial infarction (STEMI ) treated with primary Percutaneous Coronary Intervention ( PCI ) : but have
  • (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

Interventions

Cholesterol, LDL

Intervention Hierarchy (Ancestors)

CholesterolSterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsLipoproteins, LDLLipoproteinsLipidsMembrane LipidsProteinsAmino Acids, Peptides, and Proteins

Central Study Contacts

alzahraa gamal, master

CONTACT

hatem abdel elrahman

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR 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

April 2, 2021

First Posted

April 8, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

April 8, 2021

Record last verified: 2021-04