A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of CIAKI in Patient With AMI Undergoing Emergency PCI

ST Elevation Myocardial Infarction Clinical Trial

— TRACK-AMI  

Official title:

A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of Contrast Induced Acute Kidney Injury in Patient With Acute Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention (TRACK-AMI)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03526367
• Other study ID #: TRACK-AMI V1.0
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 20, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2019
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast-induced Acute Kidney Injury
• Emergencies
• Hydration
• Infarction
• Myocardial Infarction
• Primary PCI
• Rosuvastatin
• ST Elevation Myocardial Infarction

Intervention

Drug:
• hydration 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
• Standard 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.

Locations

Country	Name	City	State
China	The General Hospital of Shenyang Millitary Region	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	The peak value of Scr		withtin 7 days before randomized
Secondary	The rate of Aggravated Heart Function	Aggravated at Least 1 Class of Heart Function	withtin 30 days before randomized
Secondary	The rate of Hospitalization for Aggravated Renal Function, Acute Renal Failure, Dialysis or Hemofiltration		withtin 30 days before randomized
Secondary	the level of hsCRP		withtin 7 days before randomized
Secondary	The Composite of all-cause death, MI, stroke, and TVR		withtin 30 days before randomized