Vascular CalcificationNCT03360331
Effect of Phosphorus on Valvular and Vascular Calcification in ESRD
An observational study of Vascular Calcification, run by Assiut University.
Trial summary
Evaluation of the calcifying effect of phosphorus on vascular smooth muscle and detect the association between serum phosphorus and valvular and vascular calcification in end stage renal disease patients Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Vascular Calcification
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Dec 2018
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: ESRD patients on regular dialysis for five years duration aging 18 to40 years old
Who may be able to join
- ESRD patients on regular dialysis of five years duration aging 18 to 40 years
Who cannot join
- patients with hypercalcemia or hyperlipidemia or diabetic patients
About this study
Evaluation of the calcifying effect of phosphorus on vascular smooth muscle and detect the association between serum phosphorus and valvular and vascular calcification in end stage renal disease patients
Read the detailed description
Cardiovascular disease (CVD) is the main cause of death in patients with end stage renal disease(ESRD). It is estimated that ESRD patients are 5 to 20 times more likely to die because of cardiovascular causes than the general population .
Traditional cardiovascular risk factors do not completely explain higher mortality rates among hemodialysis patients , and non traditional risk factors such as anemia, bone mineral disease, hyperhomocysteinemia, inflammation, hypercoagulability, and left ventricular hypertrophy (LVH) have been demonstrated to play an important role in this population.
A number of factors have been associated with progression of vascular calcification(VC) in dialysis patients. Associations with age and duration of dialysis , diabetes mellitus ,abnormalities of mineral metabolism as well as use and dose of calcium based phosphate binders have all been reported.
Hyperphosphatemia is a common problem among patients with ESRD. It is a highly prevalent condition, as almost 40% of the U.S. hemodialysis population has a serum phosphate( PO4) greater than 6.5 mg/dl . The overall mortality risk associated with serum phosphate( PO4) above 6.5 mg/dl was 27% greater than that of patients with PO4 levels between 2.4 and 6.5 mg/dl. It is speculated that elevate PO4 may aggravate the effects of coronary atherosclerosis through increased vascular calcification and smooth muscle proliferation . It has also been suggested that myocardial calcification, a consequence of elevated PO4, may alter microcirculatory hemodynamics through increased extravascular resistance and further compromise myocardial perfusion. We, therefore, hypothesized that the increased mortality risk associated with elevated PO4 levels was primarily related to cardiac rather than non-cardiac causes of death.
A number of non-invasive imaging techniques are now available to detect and quantify vascular calcification (VC). Indeed, plain x-rays of abdomen and extremities to identify macroscopic calcifications of aorta and peripheral arteries;echocardiography for assessment of valvular calcification;2D-ultrasound for calcification of carotid arteries, femoral arteries and aorta and computed tomography technologies constitute the current armamentarium for detection and quantification of cardiovascular calcification (VC) and its progression.
Electron beam computed tomography (EBCT) and multi-slice computed tomography (MSCT) represent the gold standard for assessing the extent of coronary artery and aorta calcification.MSCT is more widely available than EBCT
- Conditions
- Vascular Calcification
- Medical subject headings
- Vascular Calcification
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease the cardiovascular complications in ESRD patients
Find the relationship between phosphorus and valvular and vascular calcification in ESRD PATIENTS
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular CalcificationStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Gamal Abdelmalik, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360331
- Sponsor's protocol ID
- calcification in ESRD
- Status last verified
- Oct 2017
- First submitted
- 5 Nov 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phosphorus on Valvular and Vascular Calcification in ESRD
- ClinicalTrials.gov ID
- NCT03360331
- Acronym / sponsor ID
- calcification in ESRD
- Conditions
- Vascular Calcification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 4 Dec 2017 (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.
Evaluation of the calcifying effect of phosphorus on vascular smooth muscle and detect the association between serum phosphorus and valvular and vascular calcification in end stage renal disease patients
Detailed description
Cardiovascular disease (CVD) is the main cause of death in patients with end stage renal disease(ESRD). It is estimated that ESRD patients are 5 to 20 times more likely to die because of cardiovascular causes than the general population .
Traditional cardiovascular risk factors do not completely explain higher mortality rates among hemodialysis patients , and non traditional risk factors such as anemia, bone mineral disease, hyperhomocysteinemia, inflammation, hypercoagulability, and left ventricular hypertrophy (LVH) have been demonstrated to play an important role in this population.
A number of factors have been associated with progression of vascular calcification(VC) in dialysis patients. Associations with age and duration of dialysis , diabetes mellitus ,abnormalities of mineral metabolism as well as use and dose of calcium based phosphate binders have all been reported.
Hyperphosphatemia is a common problem among patients with ESRD. It is a highly prevalent condition, as almost 40% of the U.S. hemodialysis population has a serum phosphate( PO4) greater than 6.5 mg/dl . The overall mortality risk associated with serum phosphate( PO4) above 6.5 mg/dl was 27% greater than that of patients with PO4 levels between 2.4 and 6.5 mg/dl. It is speculated that elevate PO4 may aggravate the effects of coronary atherosclerosis through increased vascular calcification and smooth muscle proliferation . It has also been suggested that myocardial calcification, a consequence of elevated PO4, may alter microcirculatory hemodynamics through increased extravascular resistance and further compromise myocardial perfusion. We, therefore, hypothesized that the increased mortality risk associated with elevated PO4 levels was primarily related to cardiac rather than non-cardiac causes of death.
A number of non-invasive imaging techniques are now available to detect and quantify vascular calcification (VC). Indeed, plain x-rays of abdomen and extremities to identify macroscopic calcifications of aorta and peripheral arteries;echocardiography for assessment of valvular calcification;2D-ultrasound for calcification of carotid arteries, femoral arteries and aorta and computed tomography technologies constitute the current armamentarium for detection and quantification of cardiovascular calcification (VC) and its progression.
Electron beam computed tomography (EBCT) and multi-slice computed tomography (MSCT) represent the gold standard for assessing the extent of coronary artery and aorta calcification.MSCT is more widely available than EBCT
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ESRD patients on regular dialysis for five years duration aging 18 to40 years old
Key inclusion criteria (1 listed)
- ESRD patients on regular dialysis of five years duration aging 18 to 40 years
Key exclusion criteria (1 listed)
- patients with hypercalcemia or hyperlipidemia or diabetic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Decrease the cardiovascular complications in ESRD patients
Time frame: one year
Find the relationship between phosphorus and valvular and vascular calcification in ESRD PATIENTS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Calcification, run by Assiut University.
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 1 inclusion and 1 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 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease the cardiovascular complications in ESRD patients (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2017.