Coronary Artery DiseasePhase 4NCT01070420
Comparison of Hyperemic Efficacy Between Central and Peripheral Adenosine Infusion for Fractional Flow Reserve (FFR) Measurement
A Phase 4 study testing FFR via central venous line and FFR via peripheral venous line in people with Coronary Artery Disease and Myocardial Ischemia, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia
- What is being tested?
- FFR via central venous line and FFR via peripheral venous line
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- non -infarct related, patients with moderate coronary artery stenosis
- normal ejection fraction on echocardiogram
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Cardiovascular Center, Seoul National University Hospital
Seoul
About this study
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.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia
- Being tested
- FFR via central venous line, FFR via peripheral venous line
- Keywords
- Adenosine, Fractional flow reserve, Hyperemia, Fractional Flow Reserve, Myocardial
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR via central venous lineOther
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.
FFR via peripheral venous lineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FFR via central venous line | Active comparator | Not described Receives: Other: FFR via central venous line |
| FFR via peripheral vein | Experimental | Not described Receives: Other: FFR via peripheral venous line |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare fractional flow reserve at maximal hyperemia
Measured: interval of 10 minutes
Secondary outcomes (1)
compare the time to maximal hyperemia and changes in heart rate
Measured: interval of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Bon- Kwon Koo, MD, PhD, Study chair, Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070420
- Sponsor's protocol ID
- D-0910-002-062
- Status last verified
- Jul 2011
- First submitted
- 10 Jan 2010
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park DW, Kim YH, Song HG, Ahn JM, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Her SH, Hur SH, Park JS, Kim MK, Choi YS, Kim HS, Cho JH, Lee SG, Park YW, Jeong MH, Lee BK, Lee NH, Lim DS, Yoon J, Seung KB, Shin WY, Rha SW, Kim KS, Tahk SJ, Park BE, Ahn T, Yang JY, Jeong YS, Rhew JH, Park SJ; IRIS-DES Investigators. Outcomes after unrestricted use of everolimus-eluting and sirolimus-eluting stents in routine clinical practice: a multicenter, prospective cohort study. Circ Cardiovasc Interv. 2012 Jun;5(3):365-71. doi: 10.1161/CIRCINTERVENTIONS.111.966549. Epub 2012 Jun 12.
PubMed 22693347Seo MK, Koo BK, Kim JH, Shin DH, Yang HM, Park KW, Lee HY, Kang HJ, Kim HS, Oh BH, Park YB. Comparison of hyperemic efficacy between central and peripheral venous adenosine infusion for fractional flow reserve measurement. Circ Cardiovasc Interv. 2012 Jun;5(3):401-5. doi: 10.1161/CIRCINTERVENTIONS.111.965392. Epub 2012 May 29.
PubMed 22647519
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hyperemic Efficacy Between Central and Peripheral Adenosine Infusion for Fractional Flow Reserve (FFR) Measurement
- ClinicalTrials.gov ID
- NCT01070420
- Acronym / sponsor ID
- D-0910-002-062
- Conditions
- Coronary Artery Disease, Myocardial Ischemia
- Keywords
- Adenosine, Fractional flow reserve, Hyperemia, Fractional Flow Reserve, Myocardial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFR via central venous line | Active comparator | Other: FFR via central venous line |
| FFR via peripheral vein | Experimental | Other: FFR via peripheral venous line |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- non -infarct related, patients with moderate coronary artery stenosis
- normal ejection fraction on echocardiogram
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFR via central venous linePatients 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. | Other | FFR via central venous line |
| FFR via peripheral venous linePatients 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. | Other | FFR via peripheral vein |
Primary outcome
compare fractional flow reserve at maximal hyperemia
Time frame: interval of 10 minutes
1 secondary outcome
compare the time to maximal hyperemia and changes in heart rate
Time frame: interval of 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2011.
- Derived from this study: PubMed 22693347Park DW, Kim YH, Song HG, Ahn JM, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Her SH, Hur SH, Park JS, Kim MK, Choi YS, Kim HS, Cho JH, Lee SG, Park YW, Jeong MH, Lee BK, Lee NH, Lim DS, Yoon J, Seung KB, Shin WY, Rha SW, Kim KS, Tahk SJ, Park BE, Ahn T, Yang JY, Jeong YS, Rhew JH, Park SJ; IRIS-DES Investigators. Outcomes after unrestricted use of everolimus-eluting and sirolimus-eluting stents in routine clinical practice: a multicenter, prospective cohort study. Circ Cardiovasc Interv. 2012 Jun;5(3):365-71. doi: 10.1161/CIRCINTERVENTIONS.111.966549. Epub 2012 Jun 12.
- Derived from this study: PubMed 22647519Seo MK, Koo BK, Kim JH, Shin DH, Yang HM, Park KW, Lee HY, Kang HJ, Kim HS, Oh BH, Park YB. Comparison of hyperemic efficacy between central and peripheral venous adenosine infusion for fractional flow reserve measurement. Circ Cardiovasc Interv. 2012 Jun;5(3):401-5. doi: 10.1161/CIRCINTERVENTIONS.111.965392. Epub 2012 May 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bon- Kwon Koo, MD, PhD study chair
Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FFR via central venous line and FFR via peripheral venous line in people with Coronary Artery Disease and Myocardial Ischemia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare fractional flow reserve at maximal hyperemia (time frame: interval of 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01070420, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2011.