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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

1,197

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach

1 country

5 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11.6 years study duration

Study Start

First participant enrolled

April 1, 2009

Completed

5.3 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed

6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed

Last Updated

November 27, 2017

Status Verified

April 1, 2009

Enrollment Period

11.6 years

First QC Date

July 7, 2014

Last Update Submit

November 24, 2017

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseAngina, StableFractional Flow Reserve, MyocardialCoronary Angiography

Outcome Measures

Primary Outcomes (1)

Spearman correlation coefficient between FFR, IMR, CFR and angiographic severity
during coronary angiography

Study Arms (4)

Korea

patients in South of Korea

United Kingdom

patients in England

Spain

patients in Spain

United State of America

patients in USA

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with stable angina

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Study Sites (5)

Keimyung University Dongsan medical center

Daegu, South Korea

COMPLETED

Inje University Ilsan Paik Hospital

Goyang, South Korea

COMPLETED

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Ulsan University Hospital, University of Ulsan College of Medicine

Ulsan, South Korea

COMPLETED

Related Publications (6)

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.
PMID: 32593698DERIVED
Hoshino M, Hamaya R, Kanaji Y, Kanno Y, Hada M, Yamaguchi M, Sumino Y, Hirano H, Horie T, Usui E, Sugiyama T, Murai T, Lee T, Yonetsu T, Lee JM, Choi KH, Hwang D, Park J, Jung JH, Kim HY, Jung HW, Cho YK, Yoon HJ, Song YB, Hahn JY, Doh JH, Nam CW, Shin ES, Hur SH, Mejia-Renteria H, Lauri F, Goto S, Macaya F, McInerney A, Gravina G, Vera R, Gonzalo N, Jimenez-Quevedo P, Nunez-Gil I, Salinas P, Nombela-Franco L, Del Trigo M, Fernandez-Ortiz A, Macaya C, Koo BK, Escaned J, Kakuta T. Sex Differences in Long-Term Outcomes in Patients With Deferred Revascularization Following Fractional Flow Reserve Assessment: International Collaboration Registry of Comprehensive Physiologic Evaluation. J Am Heart Assoc. 2020 Feb 18;9(4):e014458. doi: 10.1161/JAHA.119.014458. Epub 2020 Feb 17.
PMID: 32063120DERIVED
Lee SH, Choi KH, Lee JM, Hwang D, Rhee TM, Park J, Kim HK, Cho YK, Yoon HJ, Park J, Song YB, Hahn JY, Doh JH, Nam CW, Shin ES, Hur SH, Koo BK. Physiologic Characteristics and Clinical Outcomes of Patients With Discordance Between FFR and iFR. JACC Cardiovasc Interv. 2019 Oct 28;12(20):2018-2031. doi: 10.1016/j.jcin.2019.06.044. Epub 2019 Sep 25.
PMID: 31563683DERIVED
Lee JM, Choi KH, Hwang D, Park J, Jung JH, Kim HY, Jung HW, Cho YK, Yoon HJ, Song YB, Hahn JY, Doh JH, Nam CW, Shin ES, Hur SH, Koo BK. Prognostic Implication of Thermodilution Coronary Flow Reserve in Patients Undergoing Fractional Flow Reserve Measurement. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1423-1433. doi: 10.1016/j.jcin.2018.05.005.
PMID: 30093048DERIVED
Lee JM, Jung JH, Hwang D, Park J, Fan Y, Na SH, Doh JH, Nam CW, Shin ES, Koo BK. Coronary Flow Reserve and Microcirculatory Resistance in Patients With Intermediate Coronary Stenosis. J Am Coll Cardiol. 2016 Mar 15;67(10):1158-1169. doi: 10.1016/j.jacc.2015.12.053.
PMID: 26965536DERIVED
Lee JM, Layland J, Jung JH, Lee HJ, Echavarria-Pinto M, Watkins S, Yong AS, Doh JH, Nam CW, Shin ES, Koo BK, Ng MK, Escaned J, Fearon WF, Oldroyd KG. Integrated physiologic assessment of ischemic heart disease in real-world practice using index of microcirculatory resistance and fractional flow reserve: insights from the International Index of Microcirculatory Resistance Registry. Circ Cardiovasc Interv. 2015 Nov;8(11):e002857. doi: 10.1161/CIRCINTERVENTIONS.115.002857.
PMID: 26499500DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAngina, Stable

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Bon-Kwon Koo, MD, PhD
Seoul national university hosptial
PRINCIPAL INVESTIGATOR
Joo Myung Lee, MD, MPH, PhD
Samsung Medical Center
PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Target Duration: 5 Years
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 10, 2014

Study Start

April 1, 2009

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

November 27, 2017

Record last verified: 2009-04

Data Sharing

IPD Sharing: Will not share

Locations

KR(5)

Clinical, Physiological and Prognostic Implication of Microvascular Status

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

Korea

United Kingdom

Spain

United State of America

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

Korea

United Kingdom

Spain

United State of America

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations