Contrast Induced NephropathyCONVINNCT01399203
Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention
An observational study of Contrast Induced Nephropathy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
To investigate the predictive value of the contrast media volume to creatinine clearance (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Contrast Induced Nephropathy
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Jan 2012
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention
Who may be able to join
- patients who agreed to stay in the hospital for 2-3 days after percutaneous coronary intervention
- provided written informed consent
- Creatinine Clearance:15-60ml/min
Who cannot join
- pregnancy
- lactation
- intravascular administration of an contrast medium within the previous seven days
- treatment with metformin
- aminoglycosides
- N-acetylcysteine (NAC)
Show all 11Show fewer
- nonsteroidal anti-inflammatory drugs within the previous 48 h
- intake of nephrotoxic drugs within the previous seven days
- history of serious reactions to contrast mediums
- severe concomitant disease
- renal transplantation , or end-stage renal disease necessitating dialysis patients who died during percutaneous coronary intervention
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ning Tan
Guangzhou, Guangdong, 510100
Ning Tan, MD, 8620-83819161, tanning100@126.com
Yong Liu, MD, 8615920172292, liuyongyisheng@126.com
About this study
To investigate the predictive value of the contrast media volume to creatinine clearance (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI
Read the detailed description
contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after unselective PCI. Receiver-operator characteristic (ROC) curves were used to identify the optimal sensitivity for the observed range of V/CrCl. The predictive value of V/CrCl for the risk of CIN was assessed using multivariate logistic regression.
- Conditions
- Contrast Induced Nephropathy
- Keywords
- contrast-induced nephropathy, contrast medium, creatinine clearance, percutaneous coronary intervention
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 |
|---|---|---|
| percutaneous coronary intervention | The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention |
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 more than 0.5 mg/dl from the baseline within 48-72 h of contrast exposure
Measured: 48-72 h
Secondary outcomes (1)
Major adverse clinical events
Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJan 2010
- Primary completionOct 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Induced NephropathyStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hainan People's Hospital, Guangdong Medical College
- Investigators
- Yong Liu, MD, Study director, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399203
- Sponsor's protocol ID
- 2009X41
- Acronym
- CONVIN
- Status last verified
- Jan 2010
- First submitted
- 19 Jul 2011
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01399203
- Acronym / sponsor ID
- CONVIN / 2009X41
- Conditions
- Contrast Induced Nephropathy
- Keywords
- contrast-induced nephropathy, contrast medium, creatinine clearance, percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Hainan People's Hospital, Guangdong Medical College
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 21 Jul 2011 (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.
To investigate the predictive value of the contrast media volume to creatinine clearance (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI
Detailed description
contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after unselective PCI. Receiver-operator characteristic (ROC) curves were used to identify the optimal sensitivity for the observed range of V/CrCl. The predictive value of V/CrCl for the risk of CIN was assessed using multivariate logistic regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| percutaneous coronary intervention | – | –The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention
Key inclusion criteria (3 listed)
- patients who agreed to stay in the hospital for 2-3 days after percutaneous coronary intervention
- provided written informed consent
- Creatinine Clearance:15-60ml/min
Key exclusion criteria (11 listed)
- pregnancy
- lactation
- intravascular administration of an contrast medium within the previous seven days
- treatment with metformin
- aminoglycosides
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: 48-72 h
Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 48-72 h of contrast exposure
1 secondary outcome
Major adverse clinical events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2011.
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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.
Yong Liu, MD study director
Guangdong Provincial People's Hospital
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, run by Guangdong Provincial People's Hospital at 1 site in China.
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 3 inclusion and 11 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 3 Aug 2011. 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 China. 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 Ning Tan, MD (86-20-83819161, tanning100@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-Induced Nephropathy (time frame: 48-72 h). 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 3 Aug 2011.