Clinical trial NCT02186093: Clinical, Physiological and Prognostic Implication of Microvascular Status
Official title: Clinical, Physiological and Prognostic Implication of Index of Microcirculatory Resistance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Angina, Stable
Fractional Flow Reserve, Myocardial
Coronary Angiography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ulsan University Hospital
name: Keimyung University
name: Inje University
name: Stanford University
name: University of Glasgow
name: Hospital San Carlos, Madrid
name: Royal Prince Alfred Hospital, Sydney, Australia
name: Samsung Medical Center
First posted: 2014-07-10
Enrollment: 1197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stable angina

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.

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

Primary outcomes:
measure: Spearman correlation coefficient between FFR, IMR, CFR and angiographic severity
timeFrame: during coronary angiography
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan medical center
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital, University of Ulsan College of Medicine
Study officials:
affiliation: Seoul national university hosptial
name: Bon-Kwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Joo Myung Lee, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.