Electrolytes in Chronic Kidney Disease Patients With Acute Coronary Syndrome

November 22, 2021 updated by: Ahmed Mohamed Youssif, Sohag University

Study of Serum Calcium and Phosphorus Level in Chronic Kidney Disease Patients With Acute Coronary Syndrome

Study of serum calcium and phosphorus level in chronic kidney disease patients and its relation to occurrence of acute coronary syndrome in them.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective study to :

  1. find the relation between electrolytes disturbance and renal diseases
  2. the effect of electrolyte abnormalities on atherosclerosis
  3. prevalence of acute coronary syndrome in patients with chronic kidney disease

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Recruiting
        • Sohag University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

two groups :

  1. CKD patients with and without dialysis who admitted to Sohag university hospital with acute coronary syndrome
  2. CKD patients with and without dialysis who admitted to Sohag university hospital with no previous or current history of acute coronary syndrome

Description

Inclusion Criteria:

  • 1-The CKD patients with or without dialysis who admitted to coronary care unit with chest pain consistent with ACS with any of following features :

    a- Electrocardiogram (ECG) changes:

  • ST elevation.
  • ST depression.
  • T wave inversion.

  • recent left bundle branch block.

    b- Troponin T elevation.

    2-The CKD patient with or without dialysis with no previous history of ACS.

Exclusion Criteria:

  1. Patients who were diagnosed with primary hyperparathyroidism.

  2. Acute Kidney injury (AKI) which is defined as any of the following:(KDIGO2012)

    • Increase in S.Cr by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48hours; or
    • Increase in S.Cr to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days;or
    • Urine volume <0.5 ml/kg/h for 6 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic Kidney Disease (CKD) patients with acute coronary syndrome

The CKD patients with or without dialysis who admitted to coronary care unit with chest pain consistent with ACS with any of following features :

  1. Electrocardiogram (ECG) changes:

    • ST elevation.
    • ST depression.
    • T wave inversion.
    • recent left bundle branch block.
  2. Troponin elevation.
Diagnostic test: Serum Calcium
  • Serum calcium level.
  • Serum phosphorus level. will be measured to all study population
Other Names:
  • serum Phosphorus
Chronic Kidney Disease (CKD) patients without acute coronary syndrome
The CKD patient with or without dialysis with no previous history of ACS.
Diagnostic test: Serum Calcium
  • Serum calcium level.
  • Serum phosphorus level. will be measured to all study population
Other Names:
  • serum Phosphorus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic kidney disease hospitalization
Time Frame: from the day of admission to the day of discharge through study completion, an average of 28 weeks, in sohag university hospital
The CKD patient with and without acute coronary syndrome and estimated hazard ratios (HR) by use of multivariable Cox regression models.
from the day of admission to the day of discharge through study completion, an average of 28 weeks, in sohag university hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 30, 2021

Primary Completion (Anticipated)

May 30, 2022

Study Completion (Anticipated)

May 30, 2022

Study Registration Dates

First Submitted

November 6, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Electrolytes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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