Statin and Post-interventional Coronary Microcirculation... | NCT01751295

Studies
Statin and Post-interventional Coronary Microcirculation Dysfunction

NCT01751295

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Dec 17, 2012Estimated

Enrollment

84Estimated

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Aug 2014Estimated

Completion Date

Aug 2014Estimated

First Submitted Date

Dec 13, 2012

First Submission Date that Met QC Criteria

Dec 13, 2012

First Posted Date

Dec 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2012

Last Update Posted Date

Dec 17, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
atorvastatin	Active Comparator	PCI with atorvastatin pre-treatment group	Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI
control	No Intervention	PCI without atorvastatin pre-treatment group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI	Drug		atorvastatin	lipinon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel		within 1 year after PCI

Secondary Outcomes

Measure	Description	Time Frame
Post-procedural troponin I		within 1 year after PCI
Post-procedural FFR		within 1 year after PCI
Post-procedural IMR comparison of target vessel with non-target vessel

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul	Gang nam-Gu, Ilwon-Dong	135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided