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出境医 / 临床实验 / CI-AKI in Patients With Stable CAD and Comorbidities. Are we Doing Better?
CI-AKI in Patients With Stable CAD and Comorbidities. Are we Doing Better?
Study Description
Brief Summary:
Patients aged 18-89 with stable CAD and comorbidities receiving optimal medical treatment requiring PCI with iodinated contrast media.
The aim of the study is to assess the prevalence of contrast-induced AKI in 2012-2013 and 2017 cohorts and to evaluate the potential risk factors of CI-AKI to better guide the prevention in patients of higher risk.
| Condition or disease | Intervention/treatment |
|---|---|
| Stable Angina Acute Kidney Injury Contrast-induced Nephropathy | Procedure: Iodinated contrast media |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 1023 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Impact of Comorbidity as a Risk Factor of Acute Kidney Injury (AKI) in Patients With Stable Coronary Artery Disease (CAD) |
| Actual Study Start Date : | May 16, 2012 |
| Actual Primary Completion Date : | October 19, 2017 |
| Actual Study Completion Date : | December 12, 2018 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| Group 1 (5-year prognosis) |
Procedure: Iodinated contrast media
Percutaneous coronary intervention with iodinated contest media
|
| Group 2 (1-year prognosis) |
Procedure: Iodinated contrast media
Percutaneous coronary intervention with iodinated contest media
|
Outcome Measures
Primary Outcome Measures :
- Overall mortality [ Time Frame: 5 years ]
- Cardiovascular mortality [ Time Frame: 5 years ]
- Myocardial infarction [ Time Frame: 5 years ]
- Stroke [ Time Frame: 5 years ]
- GI bleeding [ Time Frame: 5 years ]
- CABG [ Time Frame: 5 years ]CABG after PCI at enrolment
- PCI [ Time Frame: 5 years ]Repeat PCI after the enrolment
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Probability Sample |
Study Population
Both genders suffering from stable coronary artery disease, requiring percutaneous coronary intervention with intra-arterial iodinated contrast injection
Criteria
Inclusion Criteria:
- Informed consent
- Male and female patients 18 y. o. and older
- Verified stable coronary artery disease (CAD)
- Receiving optimal medical treatment and requiring percutaneous coronary intervention (PCI) with iodinated contrast media
Exclusion Criteria:
- Pregnancy, lactation
- Conditions affecting the prognosis (kidney failure, liver failure, oncology)
- Acute coronary syndrome (ACS)
- Stroke
- Contraindications to PCI
- Therapy with nephrotoxic drugs during the enrolment which cannot be stopped
- Refusal to sign the informed consent
Contacts and Locations
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 7, 2019 | ||||
| First Posted Date | July 10, 2019 | ||||
| Last Update Posted Date | October 29, 2019 | ||||
| Actual Study Start Date | May 16, 2012 | ||||
| Actual Primary Completion Date | October 19, 2017 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | CI-AKI in Patients With Stable CAD and Comorbidities. Are we Doing Better? | ||||
| Official Title | The Impact of Comorbidity as a Risk Factor of Acute Kidney Injury (AKI) in Patients With Stable Coronary Artery Disease (CAD) | ||||
| Brief Summary |
Patients aged 18-89 with stable CAD and comorbidities receiving optimal medical treatment requiring PCI with iodinated contrast media. The aim of the study is to assess the prevalence of contrast-induced AKI in 2012-2013 and 2017 cohorts and to evaluate the potential risk factors of CI-AKI to better guide the prevention in patients of higher risk. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Both genders suffering from stable coronary artery disease, requiring percutaneous coronary intervention with intra-arterial iodinated contrast injection | ||||
| Condition |
|
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| Intervention | Procedure: Iodinated contrast media
Percutaneous coronary intervention with iodinated contest media
|
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
1023 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | December 12, 2018 | ||||
| Actual Primary Completion Date | October 19, 2017 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 89 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04014153 | ||||
| Other Study ID Numbers | 1/13 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Olga Mironova, I.M. Sechenov First Moscow State Medical University | ||||
| Study Sponsor | I.M. Sechenov First Moscow State Medical University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | I.M. Sechenov First Moscow State Medical University | ||||
| Verification Date | October 2019 | ||||
