Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial

NCT ID: NCT02208388

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-12

Study Completion Date

2028-03-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Computed tomography perfusion

Patients with Computed tomography perfusion

Group Type EXPERIMENTAL

computed tomography perfusion guided treatment

Intervention Type DEVICE

Fractional flow reserve

Patients with Fractional flow reserve

Group Type ACTIVE_COMPARATOR

Fractional flow reserve guided treatment

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

computed tomography perfusion guided treatment

Intervention Type DEVICE

Fractional flow reserve guided treatment

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Young-Hak Kim, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Young-Hak Kim, MD, PhD

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Byoung-Wook Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital, Yonsei University College of Medicine

Young-Hak Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asan Medical Center

Seoul, Songpa-Gu, South Korea

Site Status RECRUITING

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status COMPLETED

Gangwon National Univ. Hospital

Chuncheon, , South Korea

Site Status COMPLETED

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status COMPLETED

Pusan National University Hospital

Pusan, , South Korea

Site Status ENROLLING_BY_INVITATION

Pusan National University Yangsan Hospital

Pusan, , South Korea

Site Status COMPLETED

Severance Hospital

Seoul, , South Korea

Site Status WITHDRAWN

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Young-Hak Kim, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Young-Hak Kim, MD, PhD

Role: primary

82-2-3010-3955

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AMCCV2014-06

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Perfusion CT Registry
NCT01696006 COMPLETED