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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

Tracking Information
First Submitted Date July 7, 2014
First Posted Date July 10, 2014
Last Update Posted Date November 27, 2017
Actual Study Start Date April 2009
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2014)
Spearman correlation coefficient between FFR, IMR, CFR and angiographic severity [ Time Frame: during coronary angiography ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical, Physiological and Prognostic Implication of Microvascular Status
Official Title Clinical, Physiological and Prognostic Implication of Index of Microcirculatory Resistance
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with stable angina
Condition Coronary Artery Disease
Intervention Not Provided
Study Groups/Cohorts
  • Korea
    patients in South of Korea
  • United Kingdom
    patients in England
  • Spain
    patients in Spain
  • United State of America
    patients in USA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 9, 2014)
1197
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02186093
Other Study ID Numbers 1404-057-573
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Data will be available when requested after discussion in steering committee
Responsible Party Seoul National University Hospital
Study Sponsor Seoul National University Hospital
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
Investigators
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul national university hosptial
Principal Investigator: Joo Myung Lee, MD, MPH, PhD Samsung Medical Center
PRS Account Seoul National University Hospital
Verification Date April 2009