Clinical, Physiological and Prognostic Implication of Microvascular Status

Coronary Artery Disease Clinical Trial

Official title:

Clinical, Physiological and Prognostic Implication of Index of Microcirculatory Resistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02186093
• Other study ID #: 1404-057-573
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2014
• Last updated: November 24, 2017
• Start date: April 2009
• Est. completion date: November 2020

Study information

• Verified date: April 2009
• Source: Seoul National University Hospital
• Contact: Joo Myung Lee, MD, MPH, PhD
• Phone: 82-10-8884-8439
• Email: drone80[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1197
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan medical center	Daegu
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ulsan University Hospital, University of Ulsan College of Medicine	Ulsan

Sponsors (9)

Lead Sponsor	Collaborator
Seoul National University Hospital	Hospital San Carlos, Madrid, Inje University, Keimyung University, Royal Prince Alfred Hospital, Sydney, Australia, Samsung Medical Center, Stanford University, Ulsan University Hospital, University of Glasgow

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spearman correlation coefficient between FFR, IMR, CFR and angiographic severity		during coronary angiography