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Clinical, Physiological and Prognostic Implication of Microvascular Status

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ClinicalTrials.gov Identifier: NCT02186093
Recruitment Status : Recruiting
First Posted : July 10, 2014
Last Update Posted : November 27, 2017
Sponsor:
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
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease
Coronary Artery Disease

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1197 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Clinical, Physiological and Prognostic Implication of Index of Microcirculatory Resistance
Actual Study Start Date : April 2009
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Group/Cohort
Korea
patients in South of Korea
United Kingdom
patients in England
Spain
patients in Spain
United State of America
patients in USA



Primary Outcome Measures :
  1. Spearman correlation coefficient between FFR, IMR, CFR and angiographic severity [ Time Frame: during coronary angiography ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stable angina
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186093


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

Locations
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Korea, Republic of
Keimyung University Dongsan medical center Completed
Daegu, Korea, Republic of
Inje University Ilsan Paik Hospital Completed
Goyang, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Bon-Kwon Koo, MD, PhD    82-2-2072-2062    bkkoo@snu.ac.kr   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Joo Myung Lee, MD, MPH, PhD    82-10-8884-8439    drone80@hanmail.net   
Principal Investigator: Joo Myung Lee, MD, MPH, PhD         
Ulsan University Hospital, University of Ulsan College of Medicine Completed
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
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
Investigators
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Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul national university hosptial
Principal Investigator: Joo Myung Lee, MD, MPH, PhD Samsung Medical Center

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02186093     History of Changes
Other Study ID Numbers: 1404-057-573
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: April 2009
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available when requested after discussion in steering committee

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seoul National University Hospital:
Coronary Artery Disease
Angina, Stable
Fractional Flow Reserve, Myocardial
Coronary Angiography

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases