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Sponsored by: |
Korea University Anam Hospital |
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Information provided by: | Korea University Anam Hospital |
ClinicalTrials.gov Identifier: | NCT00536887 |
Many data indicate that statins increase mobilization of bone marrow-derived stem cells, and circulating bone marrow-derived stem cells are capable of homing to sites of myocardial infarction and endothelial disruption, thereby restoring myocardial function and microvascular integrity after acute myocardial infarction. Atorvastatin is widely used in the treatment of hyperlipidemia, especially after acute myocardial infarction. High-dose atorvastatin has been known to stop the progression of atherosclerosis and to decrease the levels of inflammatory markers. The purpose of this prospective, randomized, single-blinded trial is to compare the effect of atorvastatin 10 mg versus 40 mg in restoring coronary flow reserve (CFR) and in serial bone marrow stem cell mobilization during the 8 months follow-up in patients with acute myocardial infarction.
Condition | Intervention | Phase |
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Acute Myocardial Infarction |
Drug: atorvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment |
Official Title: | Phase 4 Study of Atorvastatin 10mg vs. 40mg in Follow-up CFR in AMI Patients |
Estimated Enrollment: | 100 |
Study Start Date: | July 2005 |
Study Completion Date: | September 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Percutaneous coronary intervention is considered as the gold standard for primary treatment after acute myocardial infarction, and clinical outcome and recovery of myocardial contractility after successful coronary intervention are influenced by the extent of microvascular damage. The use of intracoronary Doppler evaluation of infarct-related coronary artery allows direct assessment of microvascular integrity after acute myocardial infarction. The assessment of coronary flow reserve should be performed at least 24 hours after acute myocardial infarction, and we will evaluate coronary flow reserve 5 days after acute myocardial infarction. Intracoronary Doppler wire will be placed just distal to the stent, and intracoronary Doppler assessment is repeated 8 months after coronary stenting at the same point.
1. Primary end point: Comparison of atorvastatin 10 mg versus 40 mg on 8 months follow-up coronary flow reserve (CFR) and on the serial changes in stem cell mobilization (CD34, CD117, CD133, CXCR4+, C-met) after acute myocardial infarction. 2. Secondary end point: Comparison of atorvastatin 10 mg versus 40 mg on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin) and on the clinical events such as cardiac death, myocardial infarction, target vessel revascularization during the 8 months of follow-up.
Study design
Study protocol
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Korea University Anam Hospital | |
Seoul, Korea, Republic of, 136-705 |
Principal Investigator: | Soon Jun Hong, MD, PhD | Korea University Anam Hospital |
Study Director: | Sang Yup Lim, MD, PhD | Korea University Anam Hospital |
Responsible Party: | Korea University Anam Hospital ( Do-Sun Lim ) |
Study ID Numbers: | CFR |
Study First Received: | September 27, 2007 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00536887 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Antimetabolites Necrosis Heart Diseases Antilipemic Agents Myocardial Ischemia Vascular Diseases |
Anticholesteremic Agents Ischemia Hydroxymethylglutaryl-CoA Reductase Inhibitors Infarction Myocardial Infarction Atorvastatin |
Antimetabolites Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Antilipemic Agents Vascular Diseases Enzyme Inhibitors Ischemia Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Necrosis Pathologic Processes Therapeutic Uses Cardiovascular Diseases Infarction Myocardial Infarction Atorvastatin |