Contrast-induced Acute Kidney Injury, Hydration, Primary PCI, Rosuvastatin, ST Elevation Myocardial Infarction
Conditions
Brief summary
The CIAKI,as the third complication of PCI, was associated with adverse cardiac events after procedure. Moreover, because the rate of periprocedure hydration is inadequate in STEMI patients before primary PCI, the incidence of CIAKI is higher significantly in these patients. The cardiovascular pleiotropic effects of statins in addition to lipid have been widely concerned. The previous studies demonstrated usage of statin in periprocedure could decrease the risk of CIAKI. Compared with hydration, the usage of statin to prevention CIAKI show the advantages in clinical practice, for example，there is no need to consider the cardiac function.The optimal strategies for preventting CIAKI in STEMI patients undergoing primary PCI needed further studies to explore. What's more, whether a synergistic effect of hydration and statin or not is unknown.
Interventions
DRUGhydration plus rosuvastatin therapy
In experimental group,a loading dose of rosuvastatin 20mg then 10 mg daily followed for at least 7 days and hydration（3ml/kg/h）last 12 hours after randomized
DRUGStandard therapy
Prohibition of use any statins from randomized to 12 hours after procedure; The hydration or not is determined by physicians but 1 ml/kg/h at most.
Sponsors
Shenyang Northern Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years old * The STEMI patients within 12 h of onset(or within 12-24 h of onset with chest pain and persistent ST-segment elevation or the presence of a new LBBB); * The patients planned primary PCI; * At least one of the following: Diabetes mellitus, Chronic Kidney Disease, Female, Elder(Age≥65), Hypertension class 3, Congestive heart failure • Voluntary signature of informed consent
Exclusion criteria
* Type 2 Myocardial infarction secondary to an ischaemic imbalance * Intolerance of statin or iodine contrast * eGFR\<30ml/min * Administration of any iodinated (e.g.CT angiography) within 14 days before enrollment * Hepatic dysfunction, ALT 3 times greater than upper normal limit * Thyreoid insufficiency * Hemodynamic instability * Have received PCI or CABG within 30 day before enrollment * Plan to perform any coronary angiography or PCI within 30 days * Have received any statins within 7 days before enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CIAKI | 7 days | CIAKI, defined an Absolute Increase in SCr ≥0.5mg/dL（≥44.2μmmol/L）or a ≥ 25% Increase in SCr From Baseline to 7 days After the Procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The peak value of Scr | withtin 7 days before randomized | — |
| The rate of Aggravated Heart Function | withtin 30 days before randomized | Aggravated at Least 1 Class of Heart Function |
| The rate of Hospitalization for Aggravated Renal Function, Acute Renal Failure, Dialysis or Hemofiltration | withtin 30 days before randomized | — |
| the level of hsCRP | withtin 7 days before randomized | — |
| The Composite of all-cause death, MI, stroke, and TVR | withtin 30 days before randomized | — |
Countries
China
Outcome results
None listed