Clinical, Physiological and Prognostic Implication of Mic... | NCT02186093

Studies
Clinical, Physiological and Prognostic Implication of Microvascular Status

NCT02186093

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Nov 27, 2017Actual

Enrollment

1,197Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

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

Apr 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009Actual

Primary Completion Date

Nov 2020Estimated

Completion Date

Nov 2020Estimated

First Submitted Date

Jul 7, 2014

First Submission Date that Met QC Criteria

Jul 9, 2014

First Posted Date

Jul 10, 2014Estimated

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

Nov 24, 2017

Last Update Posted Date

Nov 27, 2017Actual

Name	Class
Ulsan University Hospital	OTHER
Keimyung University	OTHER
Inje University	OTHER
Stanford University

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

There are several physiologic parameters in evaluating cardiovascular disease. This study will reveal which parameter is the most proper value in predicting disease severity and risk factors of patients.

Detailed Description

Fractional Flow Reserve (FFR), index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) will be measured in stable angina patients before coronary intervention.

Relationship between angiographic characteristics of patients and FFR, IMR, CFR will be analyzed. Comparison of risk factors and prognosis between parameters will be also analyzed. This study will evaluate that which parameter is correlate with disease severity and risk factors of patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,197Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Korea		patients in South of Korea
United Kingdom		patients in England
Spain		patients in Spain
United State of America		patients in USA

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spearman correlation coefficient between FFR, IMR, CFR and angiographic severity		during coronary angiography

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18
Patients with stable angina
FFR, IMR, CFR were measured before coronary intervention

Exclusion Criteria:

Patients who have severe side effects or contraindication to hyperemic agents (ex. adenosine)
Patients with hemodynamic instability
elevation of cardiac enzymes, evidence of acute MI, or a culprit vessel of acute coronary syndrome

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with stable angina

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joo Myung Lee, MD, MPH, PhD	Contact	82-10-8884-8439		drone80@hanmail.net
Bon-Kwon Koo, MD, PhD	Contact	82-2-2072-2062		bkkoo@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Bon-Kwon Koo, MD, PhD	Seoul national university hosptial	Principal Investigator
Joo Myung Lee, MD, MPH, PhD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Keimyung University Dongsan medical center	Completed	Daegu			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32593698	Derived	Chung JH, Lee KE, Lee JM, Her AY, Kim CH, Choi KH, Song YB, Hahn JY, Kim HY, Choi JH, Garg S, Doh JH, Nam CW, Koo BK, Shin ES. Effect of Sex Difference of Coronary Microvascular Dysfunction on Long-Term Outcomes in Deferred Lesions. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1669-1679. doi: 10.1016/j.jcin.2020.04.002. Epub 2020 Jun 24.
32063120

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

ID	Term
D003324	Coronary Artery Disease
D060050	Angina, Stable