Sequential Coronary CT-angiography and Biomarkers

Coronary Artery Disease Clinical Trial

— PARSEC-NET  

Official title:

Prediction of Atherosclerotic Plaque Burden Progression With Sequential Coronary CT-angiography and Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02394262
• Other study ID #: NL49261.068.14
• Status: Recruiting
• Phase: N/A
• First received: March 4, 2015
• Last updated: March 27, 2017
• Start date: March 2015
• Est. completion date: November 2019

Study information

• Verified date: March 2017
• Source: Maastricht University Medical Center
• Contact: Bas Kietselaer, MD, PhD
• Phone: +31433871587
• Email: b.kietselaer[@]mumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Radiation:
• Coronary CT-angiography
Sequential CCTA after one year follow-up. The first CCTA will be performed in terms of diagnostic work-up (referral outpatient Cardiology department).

Other:
• Assesment of biomarkers involved in atherothrombosis
Sequential assesment of atherothrombis biomarkers: baseline and at 1 year follow-up.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque progression as defined by sequential CCTA using dedicated software.		1 year.