Coronary Artery DiseaseNCT02186093
Clinical, Physiological and Prognostic Implication of Microvascular Status
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,197 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Apr 2009to Nov 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable angina
Who may be able to join
- Age ≥ 18
- Patients with stable angina
- FFR, IMR, CFR were measured before coronary intervention
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites, 2 recruiting
- Completed
Keimyung University Dongsan medical center
Daegu
- Completed
Inje University Ilsan Paik Hospital
Goyang
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Bon-Kwon Koo, MD, PhD, 82-2-2072-2062, bkkoo@snu.ac.kr
- Recruiting
Samsung Medical Center
Seoul
Joo Myung Lee, MD, MPH, PhD, 82-10-8884-8439, drone80@hanmail.net
Joo Myung Lee, MD, MPH, PhD
- Completed
Ulsan University Hospital, University of Ulsan College of Medicine
Ulsan
About this study
Official title: Clinical, Physiological and Prognostic Implication of Index of Microcirculatory Resistance
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Angina, Stable, Fractional Flow Reserve, Myocardial, Coronary Angiography
- Medical subject headings
- Coronary Artery Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Korea | patients in South of Korea | |
| United Kingdom | patients in England | |
| Spain | patients in Spain | |
| United State of America | patients in USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spearman correlation coefficient between FFR, IMR, CFR and angiographic severity
Measured: during coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startApr 2009
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,197 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ulsan University Hospital, Keimyung University, Inje University, Stanford University, University of Glasgow, Hospital San Carlos, Madrid, Royal Prince Alfred Hospital, Sydney, Australia, Samsung Medical Center
- Responsible party
- Sponsor
- Investigators
- Bon-Kwon Koo, MD, PhD, Principal investigator, Seoul national university hosptialJoo Myung Lee, MD, MPH, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186093
- Sponsor's protocol ID
- 1404-057-573
- Status last verified
- Apr 2009
- First submitted
- 7 Jul 2014
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available when requested after discussion in steering committee
Publications
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.
PubMed 32593698Hoshino 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.
PubMed 32063120Lee 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.
PubMed 31563683Lee 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.
PubMed 30093048Lee 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.
PubMed 26965536Lee 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.
PubMed 26499500
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Physiological and Prognostic Implication of Index of Microcirculatory Resistance
- ClinicalTrials.gov ID
- NCT02186093
- Acronym / sponsor ID
- 1404-057-573
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Angina, Stable, Fractional Flow Reserve, Myocardial, Coronary Angiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,197 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ulsan University Hospital, Keimyung University, Inje University, Stanford University, University of Glasgow, Hospital San Carlos, Madrid, Royal Prince Alfred Hospital, Sydney, Australia, Samsung Medical Center
- Study start
- Apr 2009 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Korea | – | –patients in South of Korea |
| United Kingdom | – | –patients in England |
| Spain | – | –patients in Spain |
| United State of America | – | –patients in USA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable angina
Key inclusion criteria (3 listed)
- Age ≥ 18
- Patients with stable angina
- FFR, IMR, CFR were measured before coronary intervention
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spearman correlation coefficient between FFR, IMR, CFR and angiographic severity
Time frame: during coronary angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Derived from this study: PubMed 32593698Chung 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.
- Derived from this study: PubMed 32063120Hoshino 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.
- Derived from this study: PubMed 31563683Lee 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.
- Derived from this study: PubMed 30093048Lee 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.
- Derived from this study: PubMed 26965536Lee 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.
- Derived from this study: PubMed 26499500Lee 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.
- Individual participant dataSharing planned: No. Data will be available when requested after discussion in steering committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bon-Kwon Koo, MD, PhD principal investigator
Seoul national university hosptial
Joo Myung Lee, MD, MPH, PhD principal investigator
Samsung Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joo Myung Lee, MD, MPH, PhD (82-10-8884-8439, drone80@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spearman correlation coefficient between FFR, IMR, CFR and angiographic severity (time frame: during coronary angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02186093, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.