Coronary DiseasePERFUSERCTNCT02208388
Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial
A study testing computed tomography perfusion guided treatment and Fractional flow reserve guided treatment in people with Coronary Disease, run by Young-Hak Kim, MD, PhD at 7 sites in South Korea.
Trial summary
The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- computed tomography perfusion guided treatment and Fractional flow reserve guided treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 12 Aug 2014to 5 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 and more
- Diagnosed angina or angina equivalent symptom or positive exercise treadmill test
- Patients with intermediate- or high-risk probability of CAD defined by Diamond and Forester
- 70 % stenosis or more in coronary CTA
- Willing to provide informed, written consent
Who cannot join
- Requirement for surgical procedure
- Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
- Recent STEMI (<5 days)
- Non STEMI, if the cardiac troponin is not stable or starting to decline
- Left ventricular ejection fraction <30%
- Life expectancy <2 years
Show all 16Show fewer
- Impaired renal function with an effective glomerular filtration rate less than 30mL/min/1.73 ㎡ or creatinine more than 2.0 mg/dL
- Undergoing evaluation for organ transplantation
- Participation or planned participation in another cardiovascular clinical trial
- Pregnancy
- Inability to take dual antiplatelet therapy for six months
- Previous CABG
- Left main disease requiring revascularization
- Any target lesion with in-stent restenosis
- NYHA class 3 or 4a
- Severe and persistent angina with severe limitation in everyday living activities (Canadian Cardiovascular Society grading Class IV)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Young-Hak Kim, MD contact
7 sites in 1 country
South Korea7 sites, 2 recruiting
- Completed
Hallym University Sacred Heart Hospital
Anyang
- Completed
Gangwon National Univ. Hospital
Chuncheon
- Completed
Keimyung University Dongsan Medical Center
Daegu
- Enrolling by invitation
Pusan National University Hospital
Pusan
- Completed
Pusan National University Yangsan Hospital
Pusan
- Recruiting
Asan Medical Center
Seoul, Songpa-Gu
Young-Hak Kim, MD, PhD, 82-2-3010-3955, mdyhkim@amc.seoul.kr
Young-Hak Kim, MD,PhD
- Withdrawn
Severance Hospital
Seoul
About this study
Official title: Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial: Ischemia-guided Revascularization Using Perfusion Coronary CT vs. Fractional Flow Reserve
The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization
- Conditions
- Coronary Disease
- Being tested
- computed tomography perfusion guided treatment, Fractional flow reserve guided treatment
- Keywords
- Computed tomography perfusion, Fractional flow reserve
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomography perfusion guided treatmentDevice
Fractional flow reserve guided treatmentDevice
| Study group | Role | What they receive |
|---|---|---|
| Computed tomography perfusion | Experimental | Patients with Computed tomography perfusion Receives: Device: computed tomography perfusion guided treatment |
| Fractional flow reserve | Active comparator | Patients with Fractional flow reserve Receives: Device: Fractional flow reserve guided treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Events
All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke
Measured: 1 year
Secondary outcomes (7)
All cause death
All cause death
Measured: 5 year
Myocardial infarction
Myocardial infarction
Measured: 5 year
Target vessel revascularization
Target vessel revascularization
Measured: 5 year
Stent thrombosis
Stent thrombosis
Measured: 5 year
Seattle Angina Questionnaire,EQ5D questionnaire
Quality of life score assessed by the EQ-5D-5L The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Higher score of EQ-5D and EQ VAS means the low quality of life. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively.
Seattle Angina Questionnaire The Seattle Angina Questionnaire (SAQ) is a vali- dated disease-specific instrument for assessing the health status of patients with coronary artery disease.
SAQ scores can be aligned with clinical constructs (eg, scores on the SAQ angina frequency scale of 0-30 points indicate daily angina, 31-60 points indicate weekly angina, 61-99 points indicate monthly angina, and 100 points indicate no angina)
Measured: 5 year
Success of intervention
Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death
Measured: 5 year
Cost effective analysis
Cost effective analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study start12 Aug 2014
- Primary completion5 Mar 2028 (estimated)
- Study completion5 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Young-Hak Kim, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Young-Hak Kim, MD, PhD, Asan Medical Center
- Investigators
- Byoung-Wook Choi, MD, Principal investigator, Severance HospitalYoung-Hak Kim, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208388
- Sponsor's protocol ID
- AMCCV2014-06
- Acronym
- PERFUSERCT
- Status last verified
- Apr 2023
- First submitted
- 31 Jul 2014
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial: Ischemia-guided Revascularization Using Perfusion Coronary CT vs. Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT02208388
- Acronym / sponsor ID
- PERFUSERCT / AMCCV2014-06
- Conditions
- Coronary Disease
- Keywords
- Computed tomography perfusion, Fractional flow reserve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Young-Hak Kim, MD, PhDUniversity, hospital or other
- Study start
- 12 Aug 2014 (actual)
- Primary completion
- 5 Mar 2028 (estimated)
- Study completion
- 5 Mar 2028 (estimated)
- First posted
- 5 Aug 2014 (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 safety and effectiveness of CTP(computed tomography perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computed tomography perfusion | Experimental | Device: computed tomography perfusion guided treatmentPatients with Computed tomography perfusion |
| Fractional flow reserve | Active comparator | Device: Fractional flow reserve guided treatmentPatients with Fractional flow reserve |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20 and more
- Diagnosed angina or angina equivalent symptom or positive exercise treadmill test
- Patients with intermediate- or high-risk probability of CAD defined by Diamond and Forester
- 70 % stenosis or more in coronary CTA
- Willing to provide informed, written consent
Key exclusion criteria (16 listed)
- Requirement for surgical procedure
- Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
- Recent STEMI (<5 days)
- Non STEMI, if the cardiac troponin is not stable or starting to decline
- Left ventricular ejection fraction <30%
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 |
|---|---|---|
| computed tomography perfusion guided treatment | Device | Computed tomography perfusion |
| Fractional flow reserve guided treatment | Device | Fractional flow reserve |
Primary outcome
Composite Events
Time frame: 1 year
All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke
7 secondary outcomes
All cause death
Time frame: 5 year
Myocardial infarction
Time frame: 5 year
Target vessel revascularization
Time frame: 5 year
Stent thrombosis
Time frame: 5 year
Seattle Angina Questionnaire,EQ5D questionnaire
Time frame: 5 year
Success of intervention
Time frame: 5 year
Cost effective analysis
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Young-Hak Kim, MD contact
Byoung-Wook Choi, MD principal investigator
Severance Hospital
Young-Hak Kim, MD principal investigator
Asan Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed tomography perfusion guided treatment and Fractional flow reserve guided treatment in people with Coronary Disease, run by Young-Hak Kim, MD, PhD at 7 sites 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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young-Hak Kim, MD (mdyhkim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Events (time frame: 1 year). 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 5 Apr 2023.