Coronary Artery DiseaseNCT02030704
CCTA-based Coronary Plaque Characterization and High-sensitive Troponin T for the Prediction of Cardiovascular Outcomes
An observational study of Coronary Artery Disease and Noninvasive Plaque Characterization, run by University Hospital Heidelberg at 2 sites in 2 countries.
Trial summary
To determine the ability of semi-automated plaque assessment in cardiac computed tomography angiography (CCTA) and high sensitive troponin T (hsTnT) for the risk stratification of patients at intermediate risk for coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Noninvasive Plaque Characterization
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2008to Sep 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients scheduled to undergo CCTA
Who may be able to join
- Clinical indication for CCTA according to the current appropriate use criteria
Who cannot join
- non-sinus rhythm
- acute coronary syndromes
- cardiomyopathies
- moderate or severe valvular disease
- elevated serum creatinine (>1.5 mg/dl)
- history or ECG signs of previous myocardial infarction
- severe iodine allergy.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
University of Heidelberg, Department of Cardiology
Heidelberg, Baden-Wurttemberg, 69120
Hungary1 site
MTA-SE Lendület Cardiovascular Imaging Research Group, Heart and Vascular Center, Semmelweis University
Budapest, 1122
About this study
Official title: Comprehensive 'Bio-Imaging' Using Quantitative Coronary Plaque Composition Assessment and the High-sensitive Troponin T for the Prediction of Cardiac Outcomes.
To determine the ability of semi-automated plaque assessment in cardiac computed tomography angiography (CCTA) and high sensitive troponin T (hsTnT) for the risk stratification of patients at intermediate risk for coronary artery disease (CAD).
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Atherosclerotic Plaque | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death
Measured: two years
Nonfatal myocardial infarction
Measured: two years
Secondary outcomes (1)
Myocardial revascularization including PCI and CABG
PCI - Percutaneous Coronary Intervention CABG - Coronary Artery Bypass Grafting
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startFeb 2008
- Primary completionSep 2018
- Study completionSep 2018
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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Semmelweis University Heart and Vascular Center, Heidelberg University
- Responsible party
- Principal investigator, GKorosoglou, University Hospital Heidelberg
- Investigators
- Grigorios Korosoglou, Prof. Dr. med., Principal investigator, University of Heidelberg, Department of Cardiology, Heidelberg, Germany.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030704
- Sponsor's protocol ID
- HDCCTA01
- Status last verified
- Sep 2018
- First submitted
- 7 Jan 2014
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Korosoglou G, Mueller D, Lehrke S, Steen H, Hosch W, Heye T, Kauczor HU, Giannitsis E, Katus HA. Quantitative assessment of stenosis severity and atherosclerotic plaque composition using 256-slice computed tomography. Eur Radiol. 2010 Aug;20(8):1841-50. doi: 10.1007/s00330-010-1753-3. Epub 2010 Mar 20.
PubMed 20306078
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive 'Bio-Imaging' Using Quantitative Coronary Plaque Composition Assessment and the High-sensitive Troponin T for the Prediction of Cardiac Outcomes.
- ClinicalTrials.gov ID
- NCT02030704
- Acronym / sponsor ID
- HDCCTA01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Semmelweis University Heart and Vascular Center, Heidelberg University
- Study start
- Feb 2008
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 8 Jan 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.
To determine the ability of semi-automated plaque assessment in cardiac computed tomography angiography (CCTA) and high sensitive troponin T (hsTnT) for the risk stratification of patients at intermediate risk for coronary artery disease (CAD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atherosclerotic Plaque | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients scheduled to undergo CCTA
Key inclusion criteria (1 listed)
- Clinical indication for CCTA according to the current appropriate use criteria
Key exclusion criteria (7 listed)
- non-sinus rhythm
- acute coronary syndromes
- cardiomyopathies
- moderate or severe valvular disease
- elevated serum creatinine (>1.5 mg/dl)
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
Cardiac death
Time frame: two years
Nonfatal myocardial infarction
Time frame: two years
1 secondary outcome
Myocardial revascularization including PCI and CABG
Time frame: two years
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 11 Sep 2018.
- Background: PubMed 20306078Korosoglou G, Mueller D, Lehrke S, Steen H, Hosch W, Heye T, Kauczor HU, Giannitsis E, Katus HA. Quantitative assessment of stenosis severity and atherosclerotic plaque composition using 256-slice computed tomography. Eur Radiol. 2010 Aug;20(8):1841-50. doi: 10.1007/s00330-010-1753-3. Epub 2010 Mar 20.
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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.
Grigorios Korosoglou, Prof. Dr. med. principal investigator
University of Heidelberg, Department of Cardiology, Heidelberg, Germany.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Noninvasive Plaque Characterization, run by University Hospital Heidelberg at 2 sites in 2 countries.
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: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Hungary. 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?
Cardiac death (time frame: two years). 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 NCT02030704, 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 11 Sep 2018.