Coronary Artery Disease, Coronary Artery Angiography, Coronary Catheterization, Contrast-induced Nephropathy, Stable Angina, Acute Coronary Syndrome
Conditions
Brief summary
In a double-blinded randomized clinical trial, all patients undergoing coronary artery catheterization who will met our criteria, will be enrolled into three groups to receive either, vitamin e, n-acetylcysteine, or placebo. The aim of study will be to compare the superiority of vitamin e over n-acetylcysteine for the prevention of contrast-induced acute kidney injury (CIAKI).
Detailed description
Patients aged ≥18 years with chronic kidney disease who undergo coronary catheterization will be enrolled into the study if they meet the inclusion criteria. Patients will be randomly assigned into three groups in a 1:1:1 ratio (Computer-generated random number will be used to assign a patient in either group): we will use simple randomization for assigning each patient in a group. The participants, physicians and outcome assessors will be blinded throughout the trial until the opening of the randomization cold. All patients will be entered into three group and they will be given normal saline 0.9%, vitamin E, NAC, and the placebos of both regimens. The vitamin E will be given as a soft gel capsule and its placebo will have the same shape and taste. The NAC will be given as an effervescent tablet with a glass of water for consumption and its placebo will also have the same shape and taste. These drugs will be given in addition to the routine hydration therapy which will be given to all patients. Primary outcome will be the development of CIAKI. Secondary outcomes will be the development of major adverse cardiovascular events and any events till evaluating the CIAKI within 48-72 hours after intervention.
Interventions
DRUGVitamin E
As a gel capsule of vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention
DRUGN-acetyl cysteine
As an effervescent tablets of NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention
DRUGPlacebo oral capsule
The placebo of vitamin E as a soft gel capsule with the consumption order similar to vitamin e group
DRUGPlacebos
The placebo of n-acetylcysteine as a tablet with the consumption order similar to n-acetylcysteine group
Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization
Sponsors
Rajaie Cardiovascular Medical and Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients aged ≥18 years with baseline estimated glomerular filtration rate (eGFR) \<60 mL/min per 1.73 m2 (based on the Modification of Diet in Renal Disease study group formula) who undergo coronary catheterization (i.e. coronary angiography and percutaneous coronary intervention \[PCI\]) will be invited to the study if they meet the inclusion criteria: stable angina with ischemia and indication for coronary angiography, non-ST-segment elevation (NSTE) acute coronary syndrome (ACS) requiring an early invasive strategy, and patients undergoing elective PCI .
Exclusion criteria
acute ST-segment elevation myocardial infarction, high-risk NSTE-ACS warranting emergency coronary angiography (\<2 hours), cardiogenic shock, pulmonary edema, overt heart failure and/or ejection fraction \<30%, ACS undergoing coronary angiography or angioplasty during the previous 5 days, sensitivity to contrast medium, recent administration of contrast medium for any reason, AKI, history of dialysis, pregnancy, newly prescribed angiotensin converting enzyme inhibitors or angiotensin receptor blockers, bleeding and/or coagulopathy diseases, and consumption of nephrotoxic drugs, vitamin E, vitamin C, or N-acetylcysteine (NAC) at least 48 hours before intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast-induced acute kidney injury | 48 to 72 hours after coronary catheterization | Contrast-induced acute kidney injury defined as an absolute increase ≥0.5 mg/dL or a relative increase ≥25% over baseline serum creatinine concentration within 48-72 hours after administration of contrast media. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the levels of serum creatinine | 48-72 hours post-procedure | Changes in serum creatinine after coronary artery catheterization |
| eGFR within 48-72 hours after coronary catheterization | 48-72 hours post-procedure | Changes in eGFR after coronary artery catheterization |
| Changes in complete blood cell count components from baseline to follow-up | 48-72 hours post-procedure | Changes in complete blood cell count components after coronary artery catheterization |
| Length of hospital stay | 48-72 hours post-procedure | Length of hospital stay |
| Requirement for renal replacement therapies | 48-72 hours post-procedure | Requirement for renal replacement therapies, ie, any kind of dialysis or renal transplantation |
| Post-procedure acute coronary syndrome (ACS) events | 48-72 hours post-procedure | Recurrent acute coronary syndrome after coronary artery catheterization |
| Post-procedure cerebrovascular events | 48-72 hours post-procedure | Cerebrovascular events after coronary artery catheterization |
| In-hospital mortality | 48-72 hours post-procedure | In-hospital mortality after coronary artery catheterization |
| Post-procedure atrial fibrillation | 48-72 hours post-procedure | Atrial fibrillation after coronary artery catheterization |
| Post-procedure bleeding | 48-72 hours post-procedure | Bleeding events after coronary artery catheterization |
| Pulmonary embolism | 48-72 hours post-procedure | Pulmonary embolism after coronary artery catheterization |
| Re-intervention | 48-72 hours post-procedure | Repeated coronary artery catheterization |
Countries
Iran
Contacts
Primary ContactYousef Rezaei, MD
Backup ContactBahram Mohebbi, MD
Outcome results
None listed