NCT05134220

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 6, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

November 6, 2021

Last Update Submit

November 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chronic kidney disease hospitalization

    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

Study Arms (2)

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

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

Interventions

Serum CalciumDIAGNOSTIC_TEST

* Serum calcium level. * Serum phosphorus level. will be measured to all study population

Also known as: serum Phosphorus
Chronic Kidney Disease (CKD) patients with acute coronary syndromeChronic Kidney Disease (CKD) patients without acute coronary syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Patients who were diagnosed with primary hyperparathyroidism.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university

Sohag, 82524, Egypt

RECRUITING

Related Publications (1)

  • Block GA, Hulbert-Shearon TE, Levin NW, Port FK. Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis. 1998 Apr;31(4):607-17. doi: 10.1053/ajkd.1998.v31.pm9531176.

    PMID: 9531176BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Ahmed M YOUSEF, M.B.B.CH

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2021

First Posted

November 24, 2021

Study Start

November 30, 2021

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

November 24, 2021

Record last verified: 2021-11

Locations