AtherosclerosisPREDICTNCT01142973
The Clinical Course of Coronary Artery Disease in Coronary Multidetector Computed Tomographic Angiogram
An observational study of Atherosclerosis and Cardiovascular Diseases, run by Inje University at 1 site in South Korea.
Trial summary
Study Type: Observational Study Design: Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease
- How many people
- 5,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2005to Dec 2010
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: present typical/atypical chest pain
Who may be able to join
- Patients with known or suspected coronary artery disease
Who cannot join
- Irregular heart beat
- Known allergy towards the contrast agent
- Renal dysfunction
- Impossible breath-hold
- Acute coronary syndrome patient
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ilsan Paik hospital
Goyang
Sung Uk Kwon, M.D., 82-31-910-7041, prof.mdksu@gmail.com
About this study
Official title: Prognostic Role of Coronary Artery plaquEs in Patients With Suspected Coronary Artery Disease Using Multislice of Computed Tomography (PREDICT)
Study Type: Observational Study Design: Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective
Read the detailed description
The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque. Using MDCT, the researchers prospectively investigate the relationship between the presence of coronary plaques and cardiovascular events
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular events
Cardiovascular death, non-fatal MI, or any stroke
Measured: 1 years after the MDCT-scan
Secondary outcomes (1)
all causes of hospitalization
Requiring hospitalization
Measured: 1 years after the MDCT-scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startSep 2005
- Primary completionAug 2010
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Investigators
- Sung Uk Kwon, M.D., Principal investigator, Inje univ. ilsan paik hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142973
- Sponsor's protocol ID
- mdksu-mdct-001
- Acronym
- PREDICT
- Status last verified
- Sep 2010
- First submitted
- 11 Jun 2010
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim JB, Rogers IS, Kwon SU. Presence of plaques predicts worse outcomes in multi-detector computed tomography in patients with stable chest pain syndrome. Int J Cardiol. 2014 May 15;173(3):570-2. doi: 10.1016/j.ijcard.2014.03.118. Epub 2014 Mar 21. No abstract available.
PubMed 24717325
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Role of Coronary Artery plaquEs in Patients With Suspected Coronary Artery Disease Using Multislice of Computed Tomography (PREDICT)
- ClinicalTrials.gov ID
- NCT01142973
- Acronym / sponsor ID
- PREDICT / mdksu-mdct-001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 14 Jun 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.
Study Type: Observational Study Design: Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective
Detailed description
The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque. Using MDCT, the researchers prospectively investigate the relationship between the presence of coronary plaques and cardiovascular events
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- present typical/atypical chest pain
Key inclusion criteria (1 listed)
- Patients with known or suspected coronary artery disease
Key exclusion criteria (5 listed)
- Irregular heart beat
- Known allergy towards the contrast agent
- Renal dysfunction
- Impossible breath-hold
- Acute coronary syndrome patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major cardiovascular events
Time frame: 1 years after the MDCT-scan
Cardiovascular death, non-fatal MI, or any stroke
1 secondary outcome
all causes of hospitalization
Time frame: 1 years after the MDCT-scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2010.
- Derived from this study: PubMed 24717325Kim JB, Rogers IS, Kwon SU. Presence of plaques predicts worse outcomes in multi-detector computed tomography in patients with stable chest pain syndrome. Int J Cardiol. 2014 May 15;173(3):570-2. doi: 10.1016/j.ijcard.2014.03.118. Epub 2014 Mar 21. No abstract available.
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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.
Sung Uk Kwon, M.D. principal investigator
Inje univ. ilsan paik hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Cardiovascular Diseases, run by Inje University 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 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: status not confirmed, as of the sponsor's last update on 13 Sep 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Uk Kwon, M.D. (82-31-910-7041, prof.mdksu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiovascular events (time frame: 1 years after the MDCT-scan). 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 NCT01142973, which also lists 1 linked publication.
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 13 Sep 2010.