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

NCT04014153 | Completed

• 1 other identifier: 1/13
• Study Type: observational
• Target: 1,023
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stable Angina; Acute Kidney Injury; Contrast-induced Nephropathy

Keywords

acute kidney injury; coronary artery disease; contrast-induced acute kidney injury; comorbidity; CI-AKI; stable CAD

Outcome Measures

Primary Outcomes (7)

• Overall mortality

  5 years

• Cardiovascular mortality

  5 years

• Myocardial infarction

  5 years

• Stroke

  5 years

• GI bleeding

  5 years

• CABG

  CABG after PCI at enrolment

  5 years

• PCI

  Repeat PCI after the enrolment

  5 years

Study Arms (2)

Group 1 (5-year prognosis)

Procedure: Iodinated contrast media

Group 2 (1-year prognosis)

Procedure: Iodinated contrast media

Interventions

Iodinated contrast media PROCEDURE

Percutaneous coronary intervention with iodinated contest media

Group 1 (5-year prognosis); Group 2 (1-year prognosis)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Both genders suffering from stable coronary artery disease, requiring percutaneous coronary intervention with intra-arterial iodinated contrast injection

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Related Publications (3)

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

  PMID: 23875199 BACKGROUND

• Mironova OI, Deev AD, Lakotka PG, Fomin VV. [Anemia as a risk factor of contrast-associated acute kidney injury]. Ter Arkh. 2020 Dec 15;92(12):48-52. doi: 10.26442/00403660.2020.12.200450. Russian.

  PMID: 33720573 DERIVED

• Mironova OI, Staroverov II, Sivakova OA, Deev AD, Fomin VV. [Contrast-induced acute kidney injury in chronic coronary artery disease patients with diabetes mellitus and obesity]. Ter Arkh. 2020 Nov 24;92(10):29-33. doi: 10.26442/00403660.2020.10.000753. Russian.

  PMID: 33346476 DERIVED

MeSH Terms

Conditions

Angina, Stable; Acute Kidney Injury; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: July 10, 2019
• Study Start: May 16, 2012
• Primary Completion: October 19, 2017
• Study Completion: December 12, 2018
• Last Updated: October 29, 2019

Record last verified: 2019-10