Contrast Induced NephropathyNCT02192372
Metabolic Syndrome and Contrast Induced Nephropathy
An observational study of Contrast Induced Nephropathy and Metabolic Syndrome, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Prevention of contrast induced nephropathy after interventional cardiologic procedures deserves close interest because of its association with prolonged hospitalization, increased cost and increased in hospital and long term mortality rates. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Contrast Induced Nephropathy, Metabolic Syndrome
- How many people
- 599 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2014to Jul 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective percutaneous coronary intervention Patients with metabolic syndrome
Who may be able to join
- Patients must be scheduled for elective percutaneous coronary intervention Clinical diagnosis of metabolic syndrome Patients must give informed consent
Who cannot join
- Acute coronary events Acute renal failure End stage renal failure requiring hemodialysis Contrast allergy and exposure to nephrotoxic agent within 1 week before percutaneous coronary intervention Exposure to contrast agent within 1 week before the procedure.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School Of Medicine, Department of Cardiology
Ankara, 06230
About this study
Official title: Impact of Metabolic Syndrome on Development of Contrast Induced Nephropathy After Elective Percutaneous Coronary Intervention
Prevention of contrast induced nephropathy after interventional cardiologic procedures deserves close interest because of its association with prolonged hospitalization, increased cost and increased in hospital and long term mortality rates. An observational prospective cohort study was designed to determine whether metabolic syndrome predicts the development of contrast induced nephropathy after elective percutaneous coronary intervention.
- Conditions
- Contrast Induced Nephropathy, Metabolic Syndrome
- Keywords
- creatinine, glomerular filtration rate, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| metabolic syndrome | Presence of 3 or more of these components: high fasting glucose (fasting serum glucose ≥ 100 mg/dl or drug treatment for elevated blood glucose), abdominal obesity (given as waist circumference > 102 cm in men and > 88 cm in women), high blood pressure (≥130/≥85 mmHg or drug treatment for hypertension), hypertriglyceridemia (serum triglycerides ≥150 mg/dl), low high-density lipoprotein cholesterol (<40 mg/dl in men and <50 mg/dl in women). | |
| control | Age and sex adjusted control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast induced nephropathy
Contrast induced nephropathy was defined as an increase in serum creatinine of >25% or >0.5 mg/dl above the baseline value 24 or 48 hours after angiography.
Measured: 24-48 hours after the percutaneous coronary intervention
Secondary outcomes (1)
glomerular filtration rate
Glomerular filtration rate was estimated using the Cockcroft-Gault formula: (140-age) x weight (kg)/ serum creatinine (mg/dl) x 72 (x 0.85 for females)
Measured: 48 hours after the percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
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 Contrast Induced NephropathyStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Prospective
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgür Ulaş Özcan, Ankara University
- Investigators
- Ozgur Ulas Ozcan, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192372
- Sponsor's protocol ID
- MetS CIN
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ozcan OU, Adanir Er H, Gulec S, Ustun EE, Gerede DM, Goksuluk H, Tulunay Kaya C, Erol C. Impact of metabolic syndrome on development of contrast-induced nephropathy after elective percutaneous coronary intervention among nondiabetic patients. Clin Cardiol. 2015 Mar;38(3):150-6. doi: 10.1002/clc.22364.
PubMed 25800136
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metabolic Syndrome on Development of Contrast Induced Nephropathy After Elective Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02192372
- Acronym / sponsor ID
- MetS CIN
- Conditions
- Contrast Induced Nephropathy, Metabolic Syndrome
- Keywords
- creatinine, glomerular filtration rate, metabolic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Jul 2014 (estimated)
- 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.
Prevention of contrast induced nephropathy after interventional cardiologic procedures deserves close interest because of its association with prolonged hospitalization, increased cost and increased in hospital and long term mortality rates. An observational prospective cohort study was designed to determine whether metabolic syndrome predicts the development of contrast induced nephropathy after elective percutaneous coronary intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metabolic syndrome | – | –Presence of 3 or more of these components: high fasting glucose (fasting serum glucose ≥ 100 mg/dl or drug treatment for elevated blood glucose), abdominal obesity (given as waist circumference > 102 cm in men and > 88 cm in women), high blood pressure (≥130/≥85 mmHg or drug treatment for hypertension), hypertriglyceridemia (serum triglycerides ≥150 mg/dl), low high-density lipoprotein cholesterol (<40 mg/dl in men and <50 mg/dl in women). |
| control | – | –Age and sex adjusted control subjects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective percutaneous coronary intervention Patients with metabolic syndrome
Key inclusion criteria (1 listed)
- Patients must be scheduled for elective percutaneous coronary intervention Clinical diagnosis of metabolic syndrome Patients must give informed consent
Key exclusion criteria (1 listed)
- Acute coronary events Acute renal failure End stage renal failure requiring hemodialysis Contrast allergy and exposure to nephrotoxic agent within 1 week before percutaneous coronary intervention Exposure to contrast agent within 1 week before the procedure.
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
Contrast induced nephropathy
Time frame: 24-48 hours after the percutaneous coronary intervention
Contrast induced nephropathy was defined as an increase in serum creatinine of >25% or >0.5 mg/dl above the baseline value 24 or 48 hours after angiography.
1 secondary outcome
glomerular filtration rate
Time frame: 48 hours after the percutaneous coronary intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Derived from this study: PubMed 25800136Ozcan OU, Adanir Er H, Gulec S, Ustun EE, Gerede DM, Goksuluk H, Tulunay Kaya C, Erol C. Impact of metabolic syndrome on development of contrast-induced nephropathy after elective percutaneous coronary intervention among nondiabetic patients. Clin Cardiol. 2015 Mar;38(3):150-6. doi: 10.1002/clc.22364.
Related trials for Contrast Induced Nephropathy
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Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
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Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
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An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT
Contrast-associated Acute Kidney Injury
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Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
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Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
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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.
Ozgur Ulas Ozcan principal investigator
Ankara University
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 Contrast Induced Nephropathy and Metabolic Syndrome, run by Ankara University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 16 Jul 2014. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Contrast induced nephropathy (time frame: 24-48 hours after the percutaneous coronary intervention). 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 NCT02192372, 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 16 Jul 2014.