Plain English Summary
Background and study aims
A myocardial infarction (MI), also known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle. Atherosclerosis is a disease in which plaque builds up inside the arteries. Arteries are blood vessels that carry oxygen-rich blood to the heart and other parts of the body. Plaque is made up of fat, cholesterol, calcium, and other substances found in the blood. Over time, plaque hardens and narrows the arteries. Acute coronary syndrome is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart.
The aim of this study is to investigate the association between shear stress and plaque growth and plaque composition changes over time in patients with acute coronary syndrome. Furthermore, the local stress inside the plaque will be calculated to investigate possible rupture risk.
Who can participate?
Patients with acute coronary syndrome that are eligible for percutaneous coronary interventions and who contain arteries that are accessible with imaging catheters. Patients will need to give their informed consent.
What does the study involve?
The study involves additional imaging of another non-treated, less severe diseased coronary artery during the percutaneous coronary intervention initiated for treatment of the most diseased coronary artery. After 1 year, imaging of the non-treated coronary artery is repeated during another percutaneous coronary intervention. During these interventions blood will be collected. Furthermore, one month after the initial procedure a computed tomography coronary angiogram is acquired. Besides, regular clinical check-ups are performed.
What are the possible benefits and risks of participating?
Intravascular coronary imaging is often part of the clinical routine in percutaneous coronary intervention as it can help the operator to achieve an optimal stent result. The burden of this study to the patient at baseline and follow-up is the additional imaging of non-treated coronary, which adds extra time to the total procedural time and a very small risk of coronary complications associated with introduction of a guide wire and imaging catheter in the coronary artery (less than 1 promille). The patient might potentially benefit from the invasive imaging in two ways. First, invasive imaging might help to reach optimal treatment of the most diseased region of the coronary artery and at follow up the treatment location will be investigated for restenosis, and if necessary re-treated. Secondly, thorough evaluation of the less severe diseased vessel might reveal additional, significant, but angiographically silent lesions warranting treatment. Recently the failure rate of angiography to visualize such additional lesions causing clinical events in the near future, has been
Where is the study run from?
The study will be run at the Thoraxcenter of the ErasmusMC Rotterdam, the Netherlands
When is the study starting and how long is it expected to run for?
August 2015 to April 2019
Who is funding the study?
The study is in part funded by the European Research Council
Who is the main contact?
Dr. ir. JJ Wentzel, j.wentzel@erasmusmc.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jolanda Wentzel
ORCID ID
http://orcid.org/0000-0001-9893-3404
Contact details
Erasmus University Medical Center
Molewaterplein 50
Rotterdam
3000 CA
Netherlands
+31 10 7044044
j.wentzel@erasmusmc.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
METC-2015-535
Study information
Scientific title
Imaging and Modeling to investigate the mutual relationship of plaque growth and biomechanical parameters in human coronary arteries
Acronym
IMPACT
Study hypothesis
The objective of this study is to investigate the association between biomechanical parameters (e.g. shear stress) and plaque geometry and composition and plaque changes over time. This study has a large potential in finding new parameters that give novel insights in plaques that might cause a myocardial infarction. Thereby this study might contribute to the identification of patients at risk of cardiovascular events in the future.
Ethics approval
Approved 05/11/2015, Medisch Ethische Toetsings Commissie of the ErasmusMC (Molewaterplein 50, Rotterdam, the Netherlands; no telephone number provided; metc@erasmusmc.nl), ref: METC-2015-535 Positief Besluit NL54519.078.15, v02
Study design
Single-center prospective observational longitudinal- study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute coronary syndrome
Intervention
This study is an observational study on atherosclerotic plaque progression in human coronary arteries. The aim of this study is to investigate the influence of biomechanical factors on plaque progression over time. The intravascular imaging of the coronary arteries that is performed at baseline and after one year follow up will be used to delineate the local atherosclerotic plaque thickness. By also analyzing the local plaque thickness at one year follow up the local plaque progression will be measured. Furthermore, biomechanical parameters will be calculated using finite element modelling using 3D reconstructions of the coronary arteries based on information from intravascular imaging and computed tomography. Moreover, plaque phenotype will be identified and used in further analysis.
Methodology:
Acute coronary syndrome patients treated for coronary artery disease at the catheterization laboratory are enrolled in this study. After treatment of the most diseased coronary artery (indication for the percutaneous coronary intervention), another less severe diseased coronary artery is imaged using multiple imaging modalities and this imaging procedure is repeated at the catheterization laboratory after one year. Furthermore at one month after the first imaging moment, the patient will undergo a CT coronary angiography procedure. Blood is collected during the baseline and follow up imaging procedure.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Shear stress measured using computational fluid dynamics in 3D reconstructions of the coronary arteries based on the imaging at baseline and categorized as low, mid or high at baseline and 1 year
2. Plaque geometry and composition (including wall thickness, cap thickness and lipids) measured at several locations in the coronary arteries using images acquired and compared for regions exposed to low, mid and high shear stress at baseline and 1 year
Secondary outcome measures
Stress inside the wall will be calculated using finite element modelling based on the images acquired at baseline and 1 year follow up
Overall trial start date
05/08/2015
Overall trial end date
17/04/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient eligible for PCI of a native coronary artery
2. Written informed consent obtained
3. Study coronary artery must be accessible to the OCT /NIRS-IVUS catheters
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Total final enrolment
56
Participant exclusion criteria
1. Unable to provide informed consent
2. Under 18 years of age
3. Hemodynamic instability
4. Cardiogenic shock
5. TIMI 0 flow at target lesion site
6. Lesion beyond acute bends or in a location within the coronary anatomy where the catheter cannot transverse
7. Bypass graft as target vessel
8. Ejection fraction less than 30%
9. Contra-indication to emergency coronary artery bypass surgery
10. No access to cardiac surgery
11. Contra-indication to treatment with aspirin, ticlopidine, clopidogrel, prasugrel, ticagrelor, or heparin
12. Renal insufficiency (creatinine clearing < 50ml/min)
13. Pregnancy or inadequate anticonception
14. History of bleeding diathesis or coagulopathy.
15. History of stroke within the past year
16. History of significant gastrointestinal bleed within the past month
Recruitment start date
03/03/2016
Recruitment end date
30/03/2018
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus University Medical Center
Molewaterplein 50
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Erasmus University Medical Center
Sponsor details
Molewaterplein 50
Rotterdam
3000 CA
Netherlands
+31 10 7033938
f.zijlstra.1@erasmusmc.nl
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
European Research Council
Alternative name(s)
ERC
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The outcome of the study will be published in scientific journals.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
01/08/2020
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN43170100_Protocol_v2.0_08Nov2016.pdf uploaded 07/08/2020