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OpenTrials
Completed

NCT Number: NCT04014153

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

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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Key information

Conditions

Stable Angina Acute Kidney Injury Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Contrast-induced Nephropathy Coronary Artery Disease Coronary Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Renal Insufficiency Signs and Symptoms Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iodinated contrast media

Procedure

Percutaneous coronary intervention with iodinated contest media

Primary outcomes

  1. Overall mortality

    Time frame: 5 years

  2. Cardiovascular mortality

    Time frame: 5 years

  3. Myocardial infarction

    Time frame: 5 years

  4. Stroke

    Time frame: 5 years

  5. GI bleeding

    Time frame: 5 years

  6. CABG

    Time frame: 5 years

    CABG after PCI at enrolment

  7. PCI

    Time frame: 5 years

    Repeat PCI after the enrolment

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Jul 10, 2019
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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