Coronary Artery DiseaseESCARGOTNCT04646278
Coronary Hemodynamics by Coronary Angiography
A study testing Hyperemic stimuli in people with Coronary Artery Disease, run by KangWon National University Hospital at 1 site in South Korea.
Trial summary
Study for developing techniques to evaluate coronary artery hemodynamic profiles by conventional angiography without more dedicated measuring devices. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Hyperemic stimuli
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Apr 2017to 25 Mar 2020
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who underwent physiologic study using a pressure wire for intermediate coronary lesion after coronary angiography
Who cannot join
- ST elevation myocardial infarction
- Cardiogenic shock
- Congestive heart failure with pulmonary edema
- LVEF < 30%
- Previous history of coronary revascularization
- Chronic total occlusion
- 3 vessel disease
- Target lesion at distal segments or branches
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kangwon National University Hospital
Chuncheon, Gangwon-do, 24289
About this study
Official title: Estimation of Coronary Artery Hemodynamic Profiles Using Cineangiography Technique
Study for developing techniques to evaluate coronary artery hemodynamic profiles by conventional angiography without more dedicated measuring devices.
Read the detailed description
- Methods: Compare TIMI frame count, coronary clearance frame count in baseline/hyperemic coronary angiography with FFR, CFR, IMR and derive correlation, receiver-operating characteristic curve to find new tools estimating coronary hemodynamics by conventional angiography only.
A TIMI frame count is measured by counting the angiographic image cine frames during a head of radiocontrast column runs from the entry of left anterior descending artery (LAD) to the distal end.
A coronary clearance frame count is measured by counting the angiographic image cine frames during a tail of radiocontrast column runs from the entry of LAD to the distal end.
Baseline angiography is performed without any stimulation and hyperemic angiography is performed after intracoronary injection of adenosine 300ug or nicorandiol 2mg.
Inclusion criteria
- Patient who underwent physiologic study using a pressure wire for intermediate coronary lesion after coronary angiography
Exclusion criteria
- ST elevation myocardial infarction
- Cardiogenic shock
- Congestive heart failure with pulmonary edema
- LVEF < 30%
- Previous history of coronary revascularization
- Chronic total occlusion
- 3 vessel disease
- Target lesion at distal segments or branches
- Conditions
- Coronary Artery Disease
- Being tested
- Hyperemic stimuli
- Keywords
- coronary artery disease, Index of microcirculatory resistance, TIMI frame count, Fractional flow reserve, Coronary flow reserve
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperemic stimuliDrug
Also called Hyperemia
Hyperemic simuli of coronary flow by adenosine or nicorandil injection
| Study group | Role | What they receive |
|---|---|---|
| Hyperemic stimuli | Experimental | Hyperemic stimuli of coronary flow by adenosine or nicorandil injection Receives: Drug: Hyperemic stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIMI frame count
frame count between the beginning and end of contrast column head
Measured: Imediately after the procedure
Coronary Clearance Frame Count
frame count between the beginning and end of contrast column tail
Measured: Imediately after the procedure
Index of microcirculatory resistance
derived from distal coronary pressure by transit time
Measured: During the procedure
Secondary outcomes (2)
Fractional flow reserve
measured by pressure wire
Measured: During the procedure
Coronary flow reserve
measured by pressure wire by thermodilution technique
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start11 Apr 2017
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients who underwent coronary angiography and further hyperemic stimui
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KangWon National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Society of Cardiology
- Responsible party
- Sponsor
- Investigators
- Bong-Ki Lee, MD, PhD, Principal investigator, KangWon National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646278
- Sponsor's protocol ID
- B-2017-01-012-015
- Acronym
- ESCARGOT
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Could be shared after necessary discussions
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Coronary Artery Hemodynamic Profiles Using Cineangiography Technique
- ClinicalTrials.gov ID
- NCT04646278
- Acronym / sponsor ID
- ESCARGOT / B-2017-01-012-015
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, Index of microcirculatory resistance, TIMI frame count, Fractional flow reserve, Coronary flow reserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KangWon National University HospitalUniversity, hospital or other
- Collaborators
- The Korean Society of Cardiology
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 27 Nov 2020 (actual)
- 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.
Study for developing techniques to evaluate coronary artery hemodynamic profiles by conventional angiography without more dedicated measuring devices.
Detailed description
- Methods: Compare TIMI frame count, coronary clearance frame count in baseline/hyperemic coronary angiography with FFR, CFR, IMR and derive correlation, receiver-operating characteristic curve to find new tools estimating coronary hemodynamics by conventional angiography only.
A TIMI frame count is measured by counting the angiographic image cine frames during a head of radiocontrast column runs from the entry of left anterior descending artery (LAD) to the distal end.
A coronary clearance frame count is measured by counting the angiographic image cine frames during a tail of radiocontrast column runs from the entry of LAD to the distal end.
Baseline angiography is performed without any stimulation and hyperemic angiography is performed after intracoronary injection of adenosine 300ug or nicorandiol 2mg.
Inclusion criteria
- Patient who underwent physiologic study using a pressure wire for intermediate coronary lesion after coronary angiography
Exclusion criteria
- ST elevation myocardial infarction
- Cardiogenic shock
- Congestive heart failure with pulmonary edema
- LVEF < 30%
- Previous history of coronary revascularization
- Chronic total occlusion
- 3 vessel disease
- Target lesion at distal segments or branches
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who underwent coronary angiography and further hyperemic stimui
| Arm | Type | Receives |
|---|---|---|
| Hyperemic stimuli | Experimental | Drug: Hyperemic stimuliHyperemic stimuli of coronary flow by adenosine or nicorandil injection |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who underwent physiologic study using a pressure wire for intermediate coronary lesion after coronary angiography
Key exclusion criteria (8 listed)
- ST elevation myocardial infarction
- Cardiogenic shock
- Congestive heart failure with pulmonary edema
- LVEF < 30%
- Previous history of coronary revascularization
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 |
|---|---|---|
| Hyperemic stimuliAlso: HyperemiaHyperemic simuli of coronary flow by adenosine or nicorandil injection | Drug | Hyperemic stimuli |
Primary outcome
TIMI frame count
Time frame: Imediately after the procedure
frame count between the beginning and end of contrast column head
Coronary Clearance Frame Count
Time frame: Imediately after the procedure
frame count between the beginning and end of contrast column tail
Index of microcirculatory resistance
Time frame: During the procedure
derived from distal coronary pressure by transit time
2 secondary outcomes
Fractional flow reserve
Time frame: During the procedure
Coronary flow reserve
Time frame: During the procedure
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 27 Nov 2020.
- Individual participant dataSharing planned: Yes. Could be shared after necessary discussions
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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.
Bong-Ki Lee, MD, PhD principal investigator
KangWon 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 study testing Hyperemic stimuli in people with Coronary Artery Disease, run by KangWon 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 1 inclusion and 8 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 27 Nov 2020. 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.
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?
TIMI frame count (time frame: Imediately after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2020.