CI-AKI in Patients With Stable CAD and Comorbidities. Are we Doing Better?

Acute Kidney Injury Clinical Trial

Official title:

The Impact of Comorbidity as a Risk Factor of Acute Kidney Injury (AKI) in Patients With Stable Coronary Artery Disease (CAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04014153
• Other study ID #: 1/13
• Status: Completed
• Start date: May 16, 2012
• Est. completion date: December 12, 2018

Study information

• Verified date: October 2019
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1023
• Est. completion date: December 12, 2018
• Est. primary completion date: October 19, 2017
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Angina, Stable
• Contrast-induced Nephropathy
• Stable Angina
• Wounds and Injuries

Intervention

Procedure:
• Iodinated contrast media
Percutaneous coronary intervention with iodinated contest media

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

References & Publications (1)

Mironova OIu. [Contrast substances-induced nephropathy]. Ter Arkh. 2013;85(6):90-5. Review. Russian. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality		5 years
Primary	Cardiovascular mortality		5 years
Primary	Myocardial infarction		5 years
Primary	Stroke		5 years
Primary	GI bleeding		5 years
Primary	CABG	CABG after PCI at enrolment	5 years
Primary	PCI	Repeat PCI after the enrolment	5 years