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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01070420
First received: January 10, 2010
Last updated: July 15, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
Myocardial Ischemia
 Other: FFR via central venous line
Other: FFR via peripheral venous line
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic

Resource links provided by NLM:

Drug Information available for: Adenosine
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • compare fractional flow reserve at maximal hyperemia [ Time Frame: interval of 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • compare the time to maximal hyperemia and changes in heart rate [ Time Frame: interval of 10 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070420

Locations
Korea, Republic of
Cardiovascular Center, Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Bon- Kwon Koo, MD, PhD Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bon- Kwon Koo / prof, Cardiovascular Center, Seoul National University Hospital,
ClinicalTrials.gov Identifier: NCT01070420     History of Changes
Other Study ID Numbers: D-0910-002-062
Study First Received: January 10, 2010
Last Updated: July 15, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Adenosine
Fractional flow reserve, Hyperemia
Fractional Flow Reserve, Myocardial

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Adenosine
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on June 18, 2013