AtherosclerosisPREDICTNCT00991835
Plaque Registration and Event Detection In Computed Tomography
An observational study of Atherosclerosis and Cardiovascular Diseases, run by Hiroshima University at 1 site in Japan.
Trial summary
Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. The natural history of individual plaques is unknown and needs to be established. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease
- How many people
- 3,015 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2009to Dec 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients reffered to cardiovascular hospital
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,
- uncontrolled heart failure,
- previous coronary bypass surgery, or pacemaker or ICD implantation, ST elevation MI or unstable hemodynamic condition,
- impossible breath-hold, OR
- end-stage cancer.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Hiroshima University Graduate School of Biomedical and Health Sciences, Department of Cardiovascular Medicine
Hiroshima, Hiroshima, 734-8551
About this study
Official title: Prospective Multicenter Study to Investigate the Relationship Between the Characteristics of Coronary Artery Plaques and Cardiovascular Events Using Multidetector Computed Tomography Coronary Angiography
Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. 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 characteristics. Using MDCT, the researchers prospectively investigate the relationship between the characterization of coronary plaques and cardiovascular events in a large multicenter study.
- 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 cardiac events (Cardiac death and acute coronary syndrome)
Measured: 2 years after the CT-scan
All-cause death
Measured: 2 years after the CT-scan
Secondary outcomes (2)
All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations)
Measured: 2 years after CT-scan
All cardiovascular events (Death, acute coronary syndrome, heart failure, cerebral disease, peripheral artery disease, aortic disease, and renal failure)
Measured: 2 years after the CT-scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2012
- Study completionDec 2014 (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
- Prospective
- Enrolment
- 3,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasuki Kihara, Hiroshima University
- Investigators
- Yasuki Kihara, MD,PhD, Study chair, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991835
- Sponsor's protocol ID
- PREDICT2009
- Acronym
- PREDICT
- Status last verified
- Mar 2013
- First submitted
- 7 Oct 2009
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yamamoto H, Awai K, Kuribayashi S, Kihara Y; PREDICT Investigators. Rationale and design of the PREDICT (Plaque Registration and Evaluation Detected In Computed Tomography) registry. J Cardiovasc Comput Tomogr. 2014 Mar-Apr;8(2):90-6. doi: 10.1016/j.jcct.2013.12.004. Epub 2014 Jan 8.
PubMed 24661823
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study to Investigate the Relationship Between the Characteristics of Coronary Artery Plaques and Cardiovascular Events Using Multidetector Computed Tomography Coronary Angiography
- ClinicalTrials.gov ID
- NCT00991835
- Acronym / sponsor ID
- PREDICT / PREDICT2009
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,015 participants (actual)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Oct 2009 (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.
Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. 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 characteristics. Using MDCT, the researchers prospectively investigate the relationship between the characterization of coronary plaques and cardiovascular events in a large multicenter study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients reffered to cardiovascular hospital
Key inclusion criteria (1 listed)
- patients with known or suspected coronary artery disease.
Key exclusion criteria (7 listed)
- irregular heart beat,
- known allergy towards the contrast agent,
- renal dysfunction,
- uncontrolled heart failure,
- previous coronary bypass surgery, or pacemaker or ICD implantation, ST elevation MI or unstable hemodynamic condition,
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 cardiac events (Cardiac death and acute coronary syndrome)
Time frame: 2 years after the CT-scan
All-cause death
Time frame: 2 years after the CT-scan
2 secondary outcomes
All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations)
Time frame: 2 years after CT-scan
All cardiovascular events (Death, acute coronary syndrome, heart failure, cerebral disease, peripheral artery disease, aortic disease, and renal failure)
Time frame: 2 years after the CT-scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
- Derived from this study: PubMed 24661823Yamamoto H, Awai K, Kuribayashi S, Kihara Y; PREDICT Investigators. Rationale and design of the PREDICT (Plaque Registration and Evaluation Detected In Computed Tomography) registry. J Cardiovasc Comput Tomogr. 2014 Mar-Apr;8(2):90-6. doi: 10.1016/j.jcct.2013.12.004. Epub 2014 Jan 8.
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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.
Yasuki Kihara, MD,PhD study chair
Hiroshima University
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 Hiroshima University at 1 site in Japan.
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 7 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 20 Mar 2013. 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 Japan. 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?
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?
Major cardiac events (Cardiac death and acute coronary syndrome) (time frame: 2 years after the CT-scan). The study lists 2 primary outcomes in all. 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 NCT00991835, 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 20 Mar 2013.