Statin and Post-interventional Coronary Microcirculation Dysfunction

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jin-Ho Choi, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01751295
First received: December 13, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751295

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  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 July 26, 2014