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Sequential Coronary CT-angiography and Biomarkers (PARSEC-NET)

Primary Purpose

Coronary Artery Disease, Atherosclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Coronary CT-angiography
Assesment of biomarkers involved in atherothrombosis
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease focused on measuring Biological Markers, Multidetector Computed Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maastricht University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Serial CCTA and atherothrombosis markers

Arm Description

Sequential coronary CT-angiography and assesment of biomarkers involved in atherothrombosis after 1 year follow-up.

Outcomes

Primary Outcome Measures

Plaque progression as defined by sequential CCTA using dedicated software.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2015
Last Updated
March 27, 2017
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02394262
Brief Title
Sequential Coronary CT-angiography and Biomarkers
Acronym
PARSEC-NET
Official Title
Prediction of Atherosclerotic Plaque Burden Progression With Sequential Coronary CT-angiography and Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Atherosclerosis
Keywords
Biological Markers, Multidetector Computed Tomography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Serial CCTA and atherothrombosis markers
Arm Type
Experimental
Arm Description
Sequential coronary CT-angiography and assesment of biomarkers involved in atherothrombosis after 1 year follow-up.
Intervention Type
Radiation
Intervention Name(s)
Coronary CT-angiography
Intervention Description
Sequential CCTA after one year follow-up. The first CCTA will be performed in terms of diagnostic work-up (referral outpatient Cardiology department).
Intervention Type
Other
Intervention Name(s)
Assesment of biomarkers involved in atherothrombosis
Intervention Description
Sequential assesment of atherothrombis biomarkers: baseline and at 1 year follow-up.
Primary Outcome Measure Information:
Title
Plaque progression as defined by sequential CCTA using dedicated software.
Time Frame
1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bas Kietselaer, MD, PhD
Phone
+31433871587
Email
b.kietselaer@mumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Sibel Altintas, MD
Phone
+31433881232
Email
s.altintas@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bas Kietselaer, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Sequential Coronary CT-angiography and Biomarkers

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