AtherosclerosisIMPROVENCT03218527
Influence of Circulating Endothelial Progenitor Cells and Modifiable Vascular Risk Factors on Carotid Plaque Vulnerability
An observational study of Atherosclerosis and Stroke, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Ischemic stroke is a leading cause of death and disability worldwide. Atherosclerosis, responsible for the 20% of ischemic strokes, is characterized by lipid accumulation in the artery wall that leads to chronic inflammation, cell proliferation and ultimately to vessel stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Stroke, Inflammation
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2015to 31 Dec 2018
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed of ischemic stroke presenting at least on atherosclerotic plaque in the internal carotid artery ipsilateral to stroke
Who may be able to join
- Ischemic stroke within 7 days before inclusion
- At least one atherosclerotic plaque in the internal carotid artery
- >18 years old
Who cannot join
- Cardioembolic strokes according to TOAST criteria
- Poor functional outcome (Rankin >3) after stroke
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Pol Camps-Renom, MD, +34660030907, pcamps@santpau.cat
About this study
Ischemic stroke is a leading cause of death and disability worldwide. Atherosclerosis, responsible for the 20% of ischemic strokes, is characterized by lipid accumulation in the artery wall that leads to chronic inflammation, cell proliferation and ultimately to vessel stenosis. One of the main features related to plaque progression and vulnerability is inflammation. Positron emission tomography with 18-fluorodeoxyglucos (18-FDG PET) allows an accurate quantification of plaque inflammation and it has been proved its usefulness in predicting early stroke recurrences. The investigators aim to test how modifiable vascular risk factors influence plaque inflammation assessed by 18-FDG PET. In addition, investigators will assess the association of this inflammation and circulating endothelial progenitor cells
- Conditions
- Atherosclerosis, Stroke, Inflammation
- Medical subject headings
- Atherosclerosis, Stroke, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Standardized Uptake Value (SUV) of the internal carotid artery
Inflammation change of the internal carotid artery assessed by the Standardized Uptake Value (SUV) obtained with 18FDG-PET scan at one-year follow-up
Measured: Baseline and at one year follow-up
Change in the Target-to-Background Ratio (TBR) of the internal carotid artery
Inflammation change of the internal carotid artery assessed by the Target-to-Background Ratio (TBR) obtained with 18FDG-PET scan at one-year follow-up
Measured: Baseline and at one year follow-up
Change in the Endothelial Progenitor Cells Count
Change in the Endothelial Progenitor Cells Count by flow cytometry
Measured: Baseline and at one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 Oct 2015
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218527
- Sponsor's protocol ID
- IIBSP-ATE-2015-38
- Acronym
- IMPROVE
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia E, Camps-Renom P, Puig N, Fernandez-Leon A, Aguilera-Simon A, Benitez-Amaro A, Sole A, Vilades D, Sanchez-Quesada JL, Marti-Fabregas J, Jimenez-Xarrie E, Benitez S, Llorente-Cortes V. Soluble low-density lipoprotein receptor-related protein 1 as a surrogate marker of carotid plaque inflammation assessed by 18F-FDG PET in patients with a recent ischemic stroke. J Transl Med. 2023 Feb 19;21(1):131. doi: 10.1186/s12967-022-03867-w.
PubMed 36805772
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Circulating Endothelial Progenitor Cells and Modifiable Vascular Risk Factors on Carotid Plaque Vulnerability
- ClinicalTrials.gov ID
- NCT03218527
- Acronym / sponsor ID
- IMPROVE / IIBSP-ATE-2015-38
- Conditions
- Atherosclerosis, Stroke, Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Oct 2015
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 14 Jul 2017 (actual)
- 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.
Ischemic stroke is a leading cause of death and disability worldwide. Atherosclerosis, responsible for the 20% of ischemic strokes, is characterized by lipid accumulation in the artery wall that leads to chronic inflammation, cell proliferation and ultimately to vessel stenosis. One of the main features related to plaque progression and vulnerability is inflammation. Positron emission tomography with 18-fluorodeoxyglucos (18-FDG PET) allows an accurate quantification of plaque inflammation and it has been proved its usefulness in predicting early stroke recurrences. The investigators aim to test how modifiable vascular risk factors influence plaque inflammation assessed by 18-FDG PET. In addition, investigators will assess the association of this inflammation and circulating endothelial progenitor cells
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed of ischemic stroke presenting at least on atherosclerotic plaque in the internal carotid artery ipsilateral to stroke
Key inclusion criteria (3 listed)
- Ischemic stroke within 7 days before inclusion
- At least one atherosclerotic plaque in the internal carotid artery
- >18 years old
Key exclusion criteria (2 listed)
- Cardioembolic strokes according to TOAST criteria
- Poor functional outcome (Rankin >3) after stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the Standardized Uptake Value (SUV) of the internal carotid artery
Time frame: Baseline and at one year follow-up
Inflammation change of the internal carotid artery assessed by the Standardized Uptake Value (SUV) obtained with 18FDG-PET scan at one-year follow-up
Change in the Target-to-Background Ratio (TBR) of the internal carotid artery
Time frame: Baseline and at one year follow-up
Inflammation change of the internal carotid artery assessed by the Target-to-Background Ratio (TBR) obtained with 18FDG-PET scan at one-year follow-up
Change in the Endothelial Progenitor Cells Count
Time frame: Baseline and at one year follow-up
Change in the Endothelial Progenitor Cells Count by flow cytometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Derived from this study: PubMed 36805772Garcia E, Camps-Renom P, Puig N, Fernandez-Leon A, Aguilera-Simon A, Benitez-Amaro A, Sole A, Vilades D, Sanchez-Quesada JL, Marti-Fabregas J, Jimenez-Xarrie E, Benitez S, Llorente-Cortes V. Soluble low-density lipoprotein receptor-related protein 1 as a surrogate marker of carotid plaque inflammation assessed by 18F-FDG PET in patients with a recent ischemic stroke. J Transl Med. 2023 Feb 19;21(1):131. doi: 10.1186/s12967-022-03867-w.
- Individual participant dataSharing planned: No
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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.
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 Atherosclerosis and Stroke, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 inclusion and 2 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 14 Jul 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 Spain. 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 Pol Camps-Remom, MD (+34660030907, pcamps@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Standardized Uptake Value (SUV) of the internal carotid artery (time frame: Baseline and at one year follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03218527, which also lists 1 linked publication.
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 14 Jul 2017.