Statin and Post-interventional Coronary Microcirculation Dysfunction
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease |
Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction |
- Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel [ Time Frame: within 1 year after PCI ] [ Designated as safety issue: No ]
- Post-procedural troponin I [ Time Frame: within 1 year after PCI ] [ Designated as safety issue: No ]
- Post-procedural FFR [ Time Frame: within 1 year after PCI ] [ Designated as safety issue: No ]
- Post-procedural IMR comparison of target vessel with non-target vessel [ Time Frame: within 1 year after PCI ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 84 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: atorvastatin
PCI with atorvastatin pre-treatment group
|
Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI
Other Name: lipinon
|
|
No Intervention: control
PCI without atorvastatin pre-treatment group
|
Detailed Description:
Development of peri-procedural myocardial infarction following percutaneous coronary intervention (PCI) is not uncommon and affects long-term prognosis. Clinical studies have shown that pre-treatment with atorvastatin reduced peri-procedural myocardial infarction in patients with stable angina. The mechanism of peri-procedural myocardial infarction is presumed to be microvascular embolization. However the direct causal relationship between statin pretreatment and prevention of microvascular dysfunction has not been investigated yet.
In this study, we will recruit symptomatic angina patients who have clinical indication of coronary angiography. At the time of enrollment, patients will be randomly assigned to pre-treatment group (atorvastatin 80 mg/d for 4 days) or control group. Percutaneous coronary intervention (PCI) will be perfomed based on the result of diagnostic coronary angiography by decision of attending physician. When PCI is performed, fractional flow reserve (FFR) and 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 year.
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A. Finished informed consent
- B. Stable angina with clinical indication of coronary angiography
- C. Age ≥ 21 year and ≤ 80 year
Exclusion Criteria:
- A.Without informed consent
- B.PCI target lesion is not adequate or not indicated for FFR/IMR study
- C.Prior myocardial infarction or interventional procedure for PCI target vessel
- D.Myocardial infarction within 30 days
- E.Usage of statin, current or within 1 month
- F.Prior bypass surgery
- G.Impaired renal function (Creatinine > 2.0 mg/dL)
- H.Impaired left ventricular function (ejection fraction < 40%)
- I.Active hepatitis or abnormal hepatic transaminase level (> 3 ULN)
- J.Contraindication for long-term antiplatelet agent or statin
- K.Planning or potential of pregnancy
- L.Neoplastic disease without evidence of treatment completion
- M.Impaired general condition
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jin-Ho Choi, professor, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01751295 History of Changes |
| Other Study ID Numbers: | 2012-08-052 |
| Study First Received: | December 13, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | South Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Atorvastatin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013