Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Hyperemic Efficacy Between Central and Peripheral Adenosine Infusion for Fractional Flow Reserve (FFR) Measurement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01070420
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : July 18, 2011
Sponsor:
Information provided by:
Seoul National University Hospital

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of the peripheral IV continuous infusion without the insertion of central venous vascular access method in the achievement of steady-state maximal coronary hyperemia compared with the central IV continuous infusion method.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Ischemia Other: FFR via central venous line Other: FFR via peripheral venous line Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Study Start Date : December 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Active Comparator: FFR via central venous line Other: FFR via central venous line
Patients with intermediate coronary artery stenosis were consecutively enrolled. FFR was measured by a standard intravenous (IV) adenosine infusion (140 μg•min-1•kg-1) via Rt central femoral vein.

Experimental: FFR via peripheral vein Other: FFR via peripheral venous line
Patients with intermediate coronary artery stenosis were consecutively enrolled. FFR was measured by a standard intravenous (IV) adenosine infusion (140 μg•min-1•kg-1) via continuous peripheral vein.




Primary Outcome Measures :
  1. compare fractional flow reserve at maximal hyperemia [ Time Frame: interval of 10 minutes ]

Secondary Outcome Measures :
  1. compare the time to maximal hyperemia and changes in heart rate [ Time Frame: interval of 10 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • non -infarct related, patients with moderate coronary artery stenosis
  • normal ejection fraction on echocardiogram

Exclusion Criteria:

  • infarct-related arteries or clinically unstable state
  • collateral blood flow to the target vessel is shown
  • atrioventricular block on electrocardiogram
  • reduced ejection fraction(<50%) or left ventricular hypertrophy on echocardiography
  • contraindication of adenosine

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): NCT01070420


Locations
Layout table for location information
Korea, Republic of
Cardiovascular Center, Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Study Chair: Bon- Kwon Koo, MD, PhD Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bon- Kwon Koo / prof, Cardiovascular Center, Seoul National University Hospital,
ClinicalTrials.gov Identifier: NCT01070420    
Other Study ID Numbers: D-0910-002-062
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: July 18, 2011
Last Verified: July 2011
Keywords provided by Seoul National University Hospital:
Adenosine
Fractional flow reserve, Hyperemia
Fractional Flow Reserve, Myocardial
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes