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Study withdrawn for no sufficient fund support.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydration plus rosuvastatin therapy | Experimental |
|
|
| Standard therapy | Active Comparator | No statin within 12 h after randomization, hydration at physicians' discretion, but no more than 1ml/kg/h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydration plus rosuvastatin therapy | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CIAKI | 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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| The peak value of Scr | withtin 7 days before randomized | |
| The rate of Aggravated Heart Function | Aggravated at Least 1 Class of Heart Function | withtin 30 days before randomized |
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Inclusion Criteria:
Diabetes mellitus, Chronic Kidney Disease, Female, Elder(Age≥65), Hypertension class 3, Congestive heart failure
• Voluntary signature of informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaling Han, MD | The General Hospital of Shenyang Millitary Region | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of Shenyang Millitary Region | Shenyang | Liaoning | China |
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| Standard therapy | Drug | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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