Acute Coronary SyndromeNCT05134220
Electrolytes in Chronic Kidney Disease Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by Sohag University at 1 site in Egypt.
Trial summary
Study of serum calcium and phosphorus level in chronic kidney disease patients and its relation to occurrence of acute coronary syndrome in them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Serum Calcium
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2021to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university
Sohag, 82524
Hassan A Elnoaman, Professor, 0934570000, president@sohag.edu.eg
About this study
Official title: 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.
Read the detailed description
Prospective study to :
- find the relation between electrolytes disturbance and renal diseases
- the effect of electrolyte abnormalities on atherosclerosis
- prevalence of acute coronary syndrome in patients with chronic kidney disease
- Conditions
- Acute Coronary Syndrome
- Being tested
- Serum Calcium
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum CalciumDiagnostic test
Also called serum Phosphorus
- Serum calcium level.
- Serum phosphorus level. will be measured to all study population
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Serum Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from the day of admission to the day of discharge through study completion, an average of 28 weeks, in sohag university hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start30 Nov 2021 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Youssif, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134220
- Sponsor's protocol ID
- Electrolytes
- Status last verified
- Nov 2021
- First submitted
- 6 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9531176
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Serum Calcium and Phosphorus Level in Chronic Kidney Disease Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05134220
- Acronym / sponsor ID
- Electrolytes
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of serum calcium and phosphorus level in chronic kidney disease patients and its relation to occurrence of acute coronary syndrome in them.
Detailed description
Prospective study to :
- find the relation between electrolytes disturbance and renal diseases
- the effect of electrolyte abnormalities on atherosclerosis
- prevalence of acute coronary syndrome in patients with chronic kidney disease
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease (CKD) patients with acute coronary syndrome | – | Diagnostic Test: Serum CalciumThe 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. |
| Chronic Kidney Disease (CKD) patients without acute coronary syndrome | – | Diagnostic Test: Serum CalciumThe CKD patient with or without dialysis with no previous history of ACS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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 :
- ST elevation.
- ST depression.
- T wave inversion.
- recent left bundle branch block.
Key exclusion criteria (5 listed)
- Patients who were diagnosed with primary hyperparathyroidism.
- Acute Kidney injury (AKI) which is defined as any of the following:(KDIGO2012)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum CalciumAlso: serum Phosphorus* Serum calcium level. * Serum phosphorus level. will be measured to all study population | Diagnostic test | Chronic Kidney Disease (CKD) patients with acute coronary syndrome, Chronic Kidney Disease (CKD) patients without acute coronary syndrome |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Background: PubMed 9531176Block 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M YOUSEF, M.B.B.CH (01067439846, ahmed011032@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05134220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.