Diabetes MellitusBIOMARKERSNCT00948116
Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes
An observational study of Diabetes Mellitus and Renal Impairment, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Patients living with diabetes mellitus have double the risk of kidney failure compared to patients without diabetes following use of dye in many x-rays and procedures to diagnose and treat narrowing of the arteries (blood vessels) in the heart that can lead to angina or a heart attack. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Renal Impairment
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jun 2009to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with diabetes mellitus and renal impairment
Who may be able to join
- Age > 18 years, known diabetes mellitus or BM on arrival consistent with probable diagnosis of diabetes, eGFR <60 ml/min
- Undergoing a PCI procedure
- Agrees to the additional collection of blood and urine samples as outlined above
- Agrees to access of their clinical records for the collection of relevant medical data
- No history or signs of drug abuse
- Able to understand and sign the written Informed Consent Form
- Able and willing to follow the Protocol requirements
Who cannot join
- Cardiogenic shock
- Pregnancy
- Patient on renal replacement therapy (haemodialysis/CAPD/renal transplant)
- Known clinically significant infection such as HIV, Hepatitis or TB
- Any patient determined not able to make a reasoned, informed consent prior to the planned interventional procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The London Chest Hospital
London, E2 9JX
AKHIL KAPUR, 0208 983 2413, akhil.kapur@bartsandthelondon.nhs.uk
KATIE QURESHI, 0208 983 2477, katie.qureshi@bartsandthelondon.nhs.uk
About this study
Official title: Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing Coronary Revascularisation
Patients living with diabetes mellitus have double the risk of kidney failure compared to patients without diabetes following use of dye in many x-rays and procedures to diagnose and treat narrowing of the arteries (blood vessels) in the heart that can lead to angina or a heart attack. Heart disease is the commonest cause of death in patients with diabetes. People with diabetes are more likely to need these tests/treatments. By identifying those at greater risk of kidney complications we may be able to make these tests/treatments safer and offer them to more patients with diabetes.
Read the detailed description
Diabetes mellitus is an important risk factor for the development of contrast induced nephropathy (CIN), acting as a 'risk multiplier', amplifying the risk of acute kidney injury in these patients. There are important prognostic implications following the development of CIN and it is associated with a significantly increased mortality at 1 year. Diabetes is a major risk factor for coronary disease and these patients often have significant co-morbidities.
Currently creatinine is used to assess risk but this often lags behind clinical status. There is a pressing need for the development of novel, specific biomarkers to improve the detection and treatment of CIN and improve patient outcome in this high risk population.
This is a single centre,study in diabetic patients already undergoing a planned procedure, that is, a percutaneous coronary intervention (PCI). They are patients who are deemed to have an enhanced risk of contrast induced nephropathy by virtue of their diabetic and renal status, the latter being defined by a reduced eGFR which is a marker of renal disease and is based on the creatinine and characteristics of the patient. No additional interventions that are not part of their routine clinical care will be undertaken in these patients. We will be identifying natural biomarkers by obtaining serum and urine samples from these patients.
From a retrospective audit of the cardiac catheter lab database and a review of the literature we have estimated that a sample size of approximately 250 patients with DM and CKD (eGFR < 60 ml/ml) will be needed. We envisage that that we will encounter at least 50 cases of CIN from this cohort. (based on an expected incidence of CIN between 15-30% in this group). Looking for a study rate difference of at least 25%, for power of 95% and confidence intervals of 95% (with Fleiss correction) we will need at least 204 evaluable patients (to avoid Type 2 error). In view of potential drop-out of 10-15% we therefore intend to recruit 250 patients By using C statistics (Receiver operator curve analysis) we will be able to confirm or otherwise that either a particular biomarker or a combination of several biomarkers within 18 hours of procedure will increase the predictive power of CIN developing 72 hours later.
As part of their normal care patients will arrive in hospital on the morning of their planned PCI. They will at some point during the day undergo their PCI. Blood and urine will be taken just prior to the procedure and then at 2 hours, 4 hours, 8 to 12 hours, pre discharge and 3 days after the PCI.
We will then analyse the samples using ELISA techniques and correlate the biomarkers with creatinine to explore which biomarkers or panel of biomarkers may be able to diagnose contrast induced nephropathy earlier than creatinine can currently.
- Conditions
- Diabetes Mellitus, Renal Impairment
- Keywords
- Diabetes mellitus, Renal Impairment, Acute Kidney Injury, Coronary revascularisation, eGFR <60ml/min
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Acute Kidney Injury
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 |
|---|---|---|
| Diabetes mellitus, renal impairment | Patients with both diabetes mellitus and eGFR <60 ml/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of contrast induced nephropathy (CIN) which will be defined as an increase in Cr of ≥ 44 μmol/l within 72 hours post-procedure.
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study start24 Jun 2009
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AKHIL KAPUR, Principal investigator, CONSULTANT CARDIOLOGIST AND HONORARY SENIOR LECTURER, BARTS AND THE LONDON NHS TRUSTKATIE QURESHI, Principal investigator, Clinical Research Fellow/Specialist Registrar, Barts and The London NHS TrustMAGDI YAQOOB, Principal investigator, PROFESSOR AND CONSULTANT NEPHROLOGIST, HEAD DEPARTMENT OF EXPERIMENTAL MEDICINE AND NEPHROLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948116
- Sponsor's protocol ID
- 09/H0703/29
- Other IDs
- REC 09/H0703/29, ReDA: 006580 QM
- Acronym
- BIOMARKERS
- Status last verified
- Dec 2024
- First submitted
- 28 Jul 2009
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing Coronary Revascularisation
- ClinicalTrials.gov ID
- NCT00948116
- Acronym / sponsor ID
- BIOMARKERS / 09/H0703/29
- Conditions
- Diabetes Mellitus, Renal Impairment
- Keywords
- Diabetes mellitus, Renal Impairment, Acute Kidney Injury, Coronary revascularisation, eGFR <60ml/min
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 24 Jun 2009 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Jul 2009 (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.
Patients living with diabetes mellitus have double the risk of kidney failure compared to patients without diabetes following use of dye in many x-rays and procedures to diagnose and treat narrowing of the arteries (blood vessels) in the heart that can lead to angina or a heart attack. Heart disease is the commonest cause of death in patients with diabetes. People with diabetes are more likely to need these tests/treatments. By identifying those at greater risk of kidney complications we may be able to make these tests/treatments safer and offer them to more patients with diabetes.
Detailed description
Diabetes mellitus is an important risk factor for the development of contrast induced nephropathy (CIN), acting as a 'risk multiplier', amplifying the risk of acute kidney injury in these patients. There are important prognostic implications following the development of CIN and it is associated with a significantly increased mortality at 1 year. Diabetes is a major risk factor for coronary disease and these patients often have significant co-morbidities.
Currently creatinine is used to assess risk but this often lags behind clinical status. There is a pressing need for the development of novel, specific biomarkers to improve the detection and treatment of CIN and improve patient outcome in this high risk population.
This is a single centre,study in diabetic patients already undergoing a planned procedure, that is, a percutaneous coronary intervention (PCI). They are patients who are deemed to have an enhanced risk of contrast induced nephropathy by virtue of their diabetic and renal status, the latter being defined by a reduced eGFR which is a marker of renal disease and is based on the creatinine and characteristics of the patient. No additional interventions that are not part of their routine clinical care will be undertaken in these patients. We will be identifying natural biomarkers by obtaining serum and urine samples from these patients.
From a retrospective audit of the cardiac catheter lab database and a review of the literature we have estimated that a sample size of approximately 250 patients with DM and CKD (eGFR < 60 ml/ml) will be needed. We envisage that that we will encounter at least 50 cases of CIN from this cohort. (based on an expected incidence of CIN between 15-30% in this group). Looking for a study rate difference of at least 25%, for power of 95% and confidence intervals of 95% (with Fleiss correction) we will need at least 204 evaluable patients (to avoid Type 2 error). In view of potential drop-out of 10-15% we therefore intend to recruit 250 patients By using C statistics (Receiver operator curve analysis) we will be able to confirm or otherwise that either a particular biomarker or a combination of several biomarkers within 18 hours of procedure will increase the predictive power of CIN developing 72 hours later.
As part of their normal care patients will arrive in hospital on the morning of their planned PCI. They will at some point during the day undergo their PCI. Blood and urine will be taken just prior to the procedure and then at 2 hours, 4 hours, 8 to 12 hours, pre discharge and 3 days after the PCI.
We will then analyse the samples using ELISA techniques and correlate the biomarkers with creatinine to explore which biomarkers or panel of biomarkers may be able to diagnose contrast induced nephropathy earlier than creatinine can currently.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes mellitus, renal impairment | – | –Patients with both diabetes mellitus and eGFR <60 ml/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes mellitus and renal impairment
Key inclusion criteria (7 listed)
- Age > 18 years, known diabetes mellitus or BM on arrival consistent with probable diagnosis of diabetes, eGFR <60 ml/min
- Undergoing a PCI procedure
- Agrees to the additional collection of blood and urine samples as outlined above
- Agrees to access of their clinical records for the collection of relevant medical data
- No history or signs of drug abuse
Key exclusion criteria (5 listed)
- Cardiogenic shock
- Pregnancy
- Patient on renal replacement therapy (haemodialysis/CAPD/renal transplant)
- Known clinically significant infection such as HIV, Hepatitis or TB
- Any patient determined not able to make a reasoned, informed consent prior to the planned interventional 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
Development of contrast induced nephropathy (CIN) which will be defined as an increase in Cr of ≥ 44 μmol/l within 72 hours post-procedure.
Time frame: up to 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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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.
AKHIL KAPUR principal investigator
CONSULTANT CARDIOLOGIST AND HONORARY SENIOR LECTURER, BARTS AND THE LONDON NHS TRUST
KATIE QURESHI principal investigator
Clinical Research Fellow/Specialist Registrar, Barts and The London NHS Trust
MAGDI YAQOOB principal investigator
PROFESSOR AND CONSULTANT NEPHROLOGIST, HEAD DEPARTMENT OF EXPERIMENTAL MEDICINE AND NEPHROLOGY
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 Diabetes Mellitus and Renal Impairment, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 7 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AKHIL KAPUR (0208 983 2413, akhil.kapur@bartsandthelondon.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of contrast induced nephropathy (CIN) which will be defined as an increase in Cr of ≥ 44 μmol/l within 72 hours post-procedure. (time frame: up to 72 hours). 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 10 Dec 2024.