Coronary ArteriosclerosisS-20130009NCT02639962
Characteristics of Culprit Lesion and Changes in Plaque Composition. A Dual Energy Cardiac CT Study
An observational study of Coronary Arteriosclerosis, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Identifying patients who are at risk for a future myocardial infarction, is still one of the biggest challenges in cardiology. In this study the investigators will investigate culprit lesion in patients with NSTEMI and the ability of cardiac CT with dual energy computed tomography (DECT) scanning to describe and… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- Cardiac CT
- Type of treatment
- Surgery or procedure
- How many people
- 135 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Sep 2017
- 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: Patients with verified NSTEMI and Patients with SAP
Who may be able to join
- Patients with NSTEMI and scheduled to CAG or patients with SAP
Who cannot join
- Not suitable to undergo CT with contrast agent:
- Known allergy-like reactions to contrast or Claustrophobia
- Atrial fibrillation or significant arrhythmia judged to potentially limit quality of CT
- Known renal failure/insufficiency or s-creatinin> 140 µmol/L.
- Severe/symptomatic thyrotoxicosis
- pacemaker
Trial locations and contacts
1 site in 1 country.
Jess Lambrechtsen, M.D contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Medical Research, OUH, Svendborg
Svendborg, 5700
Hussam Sheta, MD, 0045 63202402
About this study
Official title: Characteristics of Culprit Lesion and Changes in Plaque Composition During Follow up in NSTEMI. A Dual Energy Cardiac CT Study
Identifying patients who are at risk for a future myocardial infarction, is still one of the biggest challenges in cardiology.
In this study the investigators will investigate culprit lesion in patients with NSTEMI and the ability of cardiac CT with dual energy computed tomography (DECT) scanning to describe and identify plaques that may be vulnerable. The investigators will also describe changes in characteristic in both stable and unstable plaques during 1 year follow up of NSTEMI and a matching group of stable angina pectoris (SAP) patients.
Read the detailed description
Patients with verified NSTEMI undergo contrast-enhanced coronary DECT before conventional coronary angiography (CAG), and DECT characteristics of the culprit lesion will be determined. All Non-culprit lesions will be observed during 2 month and 1 year follow up characteristics and changes in plaque composition, volume and core content will be assessed.
Patients with SAP undergo a baseline DECT similar to NSTEMI group. Because the expected change in coronary plaques in SAP group is minimal, there is no need for follow up at 2 month.
- Conditions
- Coronary Arteriosclerosis
- Being tested
- Cardiac CT
- Keywords
- culprit lesion, arteriosclerosis, cardiac CT
- Medical subject headings
- Coronary Artery Disease, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CTRadiation
Cardiac CT before the CAG, and follow up after 2 month and 12 month
| Study group | Role | What they receive |
|---|---|---|
| NSTEMI | patients hospitalized with NSTEMI diagnosed according to the national Danish guidelines, and are scheduled to coronary angiography. Receives: Radiation: Cardiac CT | |
| patients with stable angina pectoris | Patients in this group have stable angina symptoms and had verified plaques by earlier CAG or Cardiac CT Receives: Radiation: Cardiac CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description and characteristics of culprit lesion by DECT. (z-value)
measure the z-value for the culprit lesion, by marking the culprit lesion with a region of interest (ROI) and the DECT will calculate the mean z-value by mg/mm^3 in the marked ROI
Measured: 72 hours
Secondary outcomes (14)
Describe if the culprit lesion contains 1: soft 2: mixed or 3: calcified tissue
Visually description if the culprit lesion contain
1: soft tissue (dark area in the scan) 3: calc (white area) or 2: mixed (combined dark and white areas)
Measured: 72 hours
Measure the volume of the culprit lesion
CT software will be automatically able to measure the volume (mm3) og culprit lesion
Measured: 72 hours
Measure the remodeling index of culprit lesion
CT software will be automatically able to measure the remodeling index in culprit lesion (mm)
Measured: 72 hours
Determine the mean Z value for non-culprit plaques containing 1: soft tissue
measure the z-value for the culprit lesion, by marking the lesion with a ROI and the DECT will calculate the mean z-value in the marked ROI
Measured: 72 hours
Determine the mean Z value for non-culprit plaques containing 1: soft tissue
measure the z-value for the culprit lesion, by marking the lesion with a ROI and the DECT will calculate the mean z-value mg/mm^3 in the marked ROI
Measured: 2 month
Determine the mean Z value for non-culprit plaques containing 1: soft tissue
measure the z-value for the culprit lesion, by marking the lesion with a ROI and the DECT will calculate the mean z-value mg/mm^3 in the marked ROI
Measured: 1 year
Determine the mean Z value for non-culprit plaques containing 2: mixed tissue
z-value mg/mm^3
Measured: 72 hours
Determine the mean Z value for non-culprit plaques containing 2: mixed tissue
z-value mg/mm^3
Measured: 2 month
Determine the mean Z value for non-culprit plaques containing 2: mixed tissue
z-value mg/mm^3
Measured: 1 year
Determine the mean Z value for non-culprit plaques containing 3: calcified tissue
z-value mg/mm^3
Measured: 72 hours
Determine the mean Z value for non-culprit plaques containing 3: calcified tissue
z-value mg/mm^3
Measured: 2 month
Determine the mean Z value for non-culprit plaques containing 3: calcified tissue
z-value mg/mm^3
Measured: 1 year
changes in non-culprit plaques during 1 year in comparison til patients with stable angina pectoris
z-value z-value mg/mm^3
Measured: 1 year
z value in myocardium related to culprit vessel compared to z-value in myocardium corresponded to non-culprit vessel
z-value z-value mg/mm^3
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussam Mahmoud Sheta, Odense University Hospital
- Investigators
- Kenneth Egstrup, Study director, Odense University Hospital, Svendborg Research Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639962
- Sponsor's protocol ID
- Challenge
- Acronym
- S-20130009
- Status last verified
- May 2017
- First submitted
- 9 Dec 2015
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Culprit Lesion and Changes in Plaque Composition During Follow up in NSTEMI. A Dual Energy Cardiac CT Study
- ClinicalTrials.gov ID
- NCT02639962
- Acronym / sponsor ID
- S-20130009 / Challenge
- Conditions
- Coronary Arteriosclerosis
- Keywords
- culprit lesion, arteriosclerosis, cardiac CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 28 Dec 2015 (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.
Identifying patients who are at risk for a future myocardial infarction, is still one of the biggest challenges in cardiology.
In this study the investigators will investigate culprit lesion in patients with NSTEMI and the ability of cardiac CT with dual energy computed tomography (DECT) scanning to describe and identify plaques that may be vulnerable. The investigators will also describe changes in characteristic in both stable and unstable plaques during 1 year follow up of NSTEMI and a matching group of stable angina pectoris (SAP) patients.
Detailed description
Patients with verified NSTEMI undergo contrast-enhanced coronary DECT before conventional coronary angiography (CAG), and DECT characteristics of the culprit lesion will be determined. All Non-culprit lesions will be observed during 2 month and 1 year follow up characteristics and changes in plaque composition, volume and core content will be assessed.
Patients with SAP undergo a baseline DECT similar to NSTEMI group. Because the expected change in coronary plaques in SAP group is minimal, there is no need for follow up at 2 month.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSTEMI | – | Radiation: Cardiac CTpatients hospitalized with NSTEMI diagnosed according to the national Danish guidelines, and are scheduled to coronary angiography. |
| patients with stable angina pectoris | – | Radiation: Cardiac CTPatients in this group have stable angina symptoms and had verified plaques by earlier CAG or Cardiac CT |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with verified NSTEMI and Patients with SAP
Key inclusion criteria (1 listed)
- Patients with NSTEMI and scheduled to CAG or patients with SAP
Key exclusion criteria (6 listed)
- Not suitable to undergo CT with contrast agent:
- Known allergy-like reactions to contrast or Claustrophobia
- Atrial fibrillation or significant arrhythmia judged to potentially limit quality of CT
- Known renal failure/insufficiency or s-creatinin> 140 µmol/L.
- Severe/symptomatic thyrotoxicosis
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 |
|---|---|---|
| Cardiac CTCardiac CT before the CAG, and follow up after 2 month and 12 month | Radiation | NSTEMI, patients with stable angina pectoris |
Primary outcome
Description and characteristics of culprit lesion by DECT. (z-value)
Time frame: 72 hours
measure the z-value for the culprit lesion, by marking the culprit lesion with a region of interest (ROI) and the DECT will calculate the mean z-value by mg/mm^3 in the marked ROI
14 secondary outcomes
Describe if the culprit lesion contains 1: soft 2: mixed or 3: calcified tissue
Time frame: 72 hours
Measure the volume of the culprit lesion
Time frame: 72 hours
Measure the remodeling index of culprit lesion
Time frame: 72 hours
Determine the mean Z value for non-culprit plaques containing 1: soft tissue
Time frame: 72 hours
Determine the mean Z value for non-culprit plaques containing 1: soft tissue
Time frame: 2 month
Determine the mean Z value for non-culprit plaques containing 1: soft tissue
Time frame: 1 year
Determine the mean Z value for non-culprit plaques containing 2: mixed tissue
Time frame: 72 hours
Determine the mean Z value for non-culprit plaques containing 2: mixed tissue
Time frame: 2 month
Determine the mean Z value for non-culprit plaques containing 2: mixed tissue
Time frame: 1 year
Determine the mean Z value for non-culprit plaques containing 3: calcified tissue
Time frame: 72 hours
Determine the mean Z value for non-culprit plaques containing 3: calcified tissue
Time frame: 2 month
Determine the mean Z value for non-culprit plaques containing 3: calcified tissue
Time frame: 1 year
changes in non-culprit plaques during 1 year in comparison til patients with stable angina pectoris
Time frame: 1 year
z value in myocardium related to culprit vessel compared to z-value in myocardium corresponded to non-culprit vessel
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
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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.
Jess Lambrechtsen, M.D contact
Kenneth Egstrup study director
Odense University Hospital, Svendborg Research Department
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 Coronary Arteriosclerosis, run by Odense University Hospital at 1 site in Denmark.
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 6 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 1 Jun 2017. 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 Denmark. 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 Hussam Sheta, M.D (+4526821681, hussam.sheta@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description and characteristics of culprit lesion by DECT. (z-value) (time frame: 72 hours). 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 1 Jun 2017.