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Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR

Information source: Central South University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stable Angina; Unstable Angina; Acute Non-ST-segment Elevation Myocardial Infarction

Intervention: loading dose atorvastatin (Drug); conventional dose atorvastatin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Central South University

Official(s) and/or principal investigator(s):
Zhishan SUN, doctor, Study Chair, Affiliation: Central South University

Overall contact:
Zhishan SUN, doctor, Phone: +8613637405536, Ext: +8673158211893, Email: clinton_sun@163.com

Summary

The purpose of this study is to determine whether preoperative loading dose atorvastatin can prevent perioperative myocardial infarction during angiography and main adverse cardiac events 1 month after operation in stable angina, unstable angina and acute non-ST-segment elevation myocardial infarction patients undergoing elective coronary angiography and PCI, and determine whether its mechanisms are associated with microcirculation resistance.

Clinical Details

Official title: Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: perioperative myocardial infarction

Secondary outcome:

major adverse cardiac events (MACE) 1 month after PCI

mortality 1 month after PCI

Detailed description: With 20 years of popularity of the clinical applications of percutaneous coronary intervention (PCI), increasing attention has been paid to postoperative myocardial injury (MI) after PCI. NAPLES II1 and ARMYDA2Studies have shown that loading dose statin therapy before PCI for ACS patients can reduce perioperative myocardial infarction and major adverse cardiac events (MACE) and mortality 1 year after PCI. The core mechanism about the effects of statins on the clinical outcomes above-mentioned, which can not been completely explained by the lipid-lowering effect, so far have not been discovered in previous studies. Thus the interest of some researchers turned to the other point of view, such as coronary microcirculation. MI after PCI is a kind of non-ST-segment elevation myocardial infarction (NSTEMI) related to coronary microcirculation, which can not been detected by coronary angiography, but can be detected by index of microcirculatory resistance (IMR) examination. In this study, we will recruit stable angina, unstable angina and acute non-ST-segment elevation myocardial infarction patients who have been confirmed by coronary angiography. At the time of enrollment, patients will be randomly assigned to loading dose group (atorvastatin 80 mg 12 hours before PCI and 40 mg 2 hours before PCI and then 20mg/d after PCI) or control group (atorvastatin 20 mg 12 hours before PCI and then 20mg/d after PCI). When PCI is performed, index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 month.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with stable angina

- Patients with unstable angina patients

- Patients with acute non STsegment elevation myocardial infarction

- Patients willing to accept the need regular follow-up of this study

- Patients 18-75 years of age

- Patients who signed an informed consent form

Exclusion Criteria:

- ST segment elevation acute myocardial infarction

- Emergency coronary angiography in patients

- Patients with abnormal liver function

- Heavily calcified, distortions coronary lesions

- LVEF <30% of patients

- eGFR<30ml/min/1. 73 Square meters

- Liver disease or a history of muscle disease

Locations and Contacts

Zhishan SUN, doctor, Phone: +8613637405536, Ext: +8673158211893, Email: clinton_sun@163.com

Xiangtan Clinical College affiliated to Central South University, Xiangtan, Hunan 411100, China; Recruiting
Zhishan SUN, doctor, Phone: +8613637405536, Ext: +8673158211893, Email: clinton_sun@163.com
Additional Information

Starting date: December 2012
Last updated: January 7, 2013

Page last updated: August 23, 2015

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