- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02394262
Sequential Coronary CT-angiography and Biomarkers (PARSEC-NET)
March 27, 2017 updated by: Maastricht University Medical Center
Prediction of Atherosclerotic Plaque Burden Progression With Sequential Coronary CT-angiography and Biomarkers
Currently, cardiac computed tomography angiography (CCTA) is a well-implemented non-invasive diagnostic imaging modality in patients with stable chest pain.
Besides conventional CT-reading, CCTA is also capable to identify several morphologic and geometric characteristics of atherosclerotic plaques.
Recently, the investigators showed that the use of semi-automated plaque quantification algorithm identified parameters predictive for acute coronary syndrome on top of clinical risk profiling and conventional CT-reading.
In addition, several atherotrombosis biomarkers, like high-sensitivity cardiac troponins, are described as related to coronary artery disease and cardiovascular events.
Prospective data with sequential analysis of atherosclerotic plaques combined with different atherothrombosis biomarkers are currently lacking, but will provide important clues about the pathophysiology of plaque progression and atherothrombosis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6202
- Recruiting
- Maastricht University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with a recent history of (a)typical chest pain, who underwent a coronary calcium score scan as well as CCTA.
- Age older than 18 years and competent to perform written informed consent.
- At least 2 coronary segments with plaques:
- 1 proximal lesion.
- At least one coronary plaque consisting of a non-calcified or mixed component.
Exclusion Criteria:
- Unstable angina.
- Renal insufficiency: calculated estimated glomerular filtration rate <45mL/min.
- Iodine allergy.
- Pregnancy.
- Known history of atrial fibrillation.
- Inconclusive baseline computed coronary CT-angiography.
- Patients which are currently on oral vitamin K antagonists.
- Patients which are currently using selective anticoagulants.
- Previous PCI.
- Previous or planned coronary artery bypass grafting.
- Patients whereby the baseline CCTA was performed by a retrospective ECG-gated 'helical' protocol due to a high (>90bpm) or irregular heart rate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Serial CCTA and atherothrombosis markers
Sequential coronary CT-angiography and assesment of biomarkers involved in atherothrombosis after 1 year follow-up.
|
Sequential CCTA after one year follow-up.
The first CCTA will be performed in terms of diagnostic work-up (referral outpatient Cardiology department).
Sequential assesment of atherothrombis biomarkers: baseline and at 1 year follow-up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plaque progression as defined by sequential CCTA using dedicated software.
Time Frame: 1 year.
|
1 year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bas Kietselaer, MD, PhD, Maastricht University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
November 1, 2018
Study Completion (Anticipated)
November 1, 2019
Study Registration Dates
First Submitted
March 4, 2015
First Submitted That Met QC Criteria
March 16, 2015
First Posted (Estimate)
March 20, 2015
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL49261.068.14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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