Cerebral InfarctionD-DimerNCT04938479
D-dimer Prognostic Marker of Cerebral Infarction After Revascularization Procedure
An observational study of Cerebral Infarction and Cerebral Infarction Recovery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Cerebral infarction is the leading cause of acquired disability in adults. Absence of biological marker used in current practice and identified as a prognostic factor for recovery. D-dimers are degradation products of stabilized fibrin translating an activation of coagulation whatever the cause. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Infarction, Cerebral Infarction Recovery
- What is being tested?
- blood sample
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 31 Oct 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients under 65 years of age who have presented a heart attack brain and undergoing a revascularization procedure
Who may be able to join
- Patients aged 18 to 65
- Cerebral infarctions undergoing a revascularization procedure by thrombolysis and / or thrombectomy, at the Amiens University Hospital between January 2015 and December 2020.
- Patients having benefited from a D-dimer assay (during their stay)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Cerebral infarction is the leading cause of acquired disability in adults. Absence of biological marker used in current practice and identified as a prognostic factor for recovery. D-dimers are degradation products of stabilized fibrin translating an activation of coagulation whatever the cause. Studies have shown that increased D-dimer levels in patients with MI is associated with a higher mortality rate, the link with post-intervention non-revascularization has been demonstrate.
The purpose of this project is to search for a correlation between the level of D-dimer and the degree of recovery evaluated by the NIHSS score
- Conditions
- Cerebral Infarction, Cerebral Infarction Recovery
- Being tested
- blood sample
- Keywords
- Cerebral Infarction, cerebral infarction recovery
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
D-dimer measurement in blood sample
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between D-dimer concentration and NIHSS score
NIHSS score is based on the clinical neurological examination of the patient. Validated by the scientific community of vascular neurology, among other things in projective clinical research. This score has high inter-observer reproducibility Expressed quantitatively on a scale of 0 to 42 for the NIHSS score A high value of the NIHSS score indicates poor recovery.
Measured: 3 months
Correlation between D-dimer concentration and NIHSS score
NIHSS score is based on the clinical neurological examination of the patient. Validated by the scientific community of vascular neurology, among other things in projective clinical research. This score has high inter-observer reproducibility Expressed quantitatively on a scale of 0 to 42 for the NIHSS score A high value of the NIHSS score indicates poor recovery.
Measured: 6 months
Correlation between D-dimer concentration and the Rankin score
Rankin Scale collected by the neurologist in consultation 3-6 months post stroke.
Expressed quantitatively on a scale of 0 to 6 for the Rankin scale. A high value of the Rankin scale indicates poor recovery.
Measured: 3 months
Correlation between D-dimer concentration and the Rankin score
Rankin Scale collected by the neurologist in consultation 3-6 months post stroke.
Expressed quantitatively on a scale of 0 to 6 for the Rankin scale. A high value of the Rankin scale indicates poor recovery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Jan 2021
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938479
- Sponsor's protocol ID
- PI2020_843_0159
- Acronym
- D-Dimer
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-dimer Prognostic Marker of Cerebral Infarction After Revascularization Procedure
- ClinicalTrials.gov ID
- NCT04938479
- Acronym / sponsor ID
- D-Dimer / PI2020_843_0159
- Conditions
- Cerebral Infarction, Cerebral Infarction Recovery
- Keywords
- Cerebral Infarction, cerebral infarction recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 24 Jun 2021 (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.
Cerebral infarction is the leading cause of acquired disability in adults. Absence of biological marker used in current practice and identified as a prognostic factor for recovery. D-dimers are degradation products of stabilized fibrin translating an activation of coagulation whatever the cause. Studies have shown that increased D-dimer levels in patients with MI is associated with a higher mortality rate, the link with post-intervention non-revascularization has been demonstrate.
The purpose of this project is to search for a correlation between the level of D-dimer and the degree of recovery evaluated by the NIHSS score
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients under 65 years of age who have presented a heart attack brain and undergoing a revascularization procedure
Key inclusion criteria (3 listed)
- Patients aged 18 to 65
- Cerebral infarctions undergoing a revascularization procedure by thrombolysis and / or thrombectomy, at the Amiens University Hospital between January 2015 and December 2020.
- Patients having benefited from a D-dimer assay (during their stay)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleD-dimer measurement in blood sample | Biological | – |
Primary outcome
Correlation between D-dimer concentration and NIHSS score
Time frame: 3 months
NIHSS score is based on the clinical neurological examination of the patient. Validated by the scientific community of vascular neurology, among other things in projective clinical research. This score has high inter-observer reproducibility Expressed quantitatively on a scale of 0 to 42 for the NIHSS score A high value of the NIHSS score indicates poor recovery.
Correlation between D-dimer concentration and NIHSS score
Time frame: 6 months
NIHSS score is based on the clinical neurological examination of the patient. Validated by the scientific community of vascular neurology, among other things in projective clinical research. This score has high inter-observer reproducibility Expressed quantitatively on a scale of 0 to 42 for the NIHSS score A high value of the NIHSS score indicates poor recovery.
Correlation between D-dimer concentration and the Rankin score
Time frame: 3 months
Rankin Scale collected by the neurologist in consultation 3-6 months post stroke. Expressed quantitatively on a scale of 0 to 6 for the Rankin scale. A high value of the Rankin scale indicates poor recovery.
Correlation between D-dimer concentration and the Rankin score
Time frame: 6 months
Rankin Scale collected by the neurologist in consultation 3-6 months post stroke. Expressed quantitatively on a scale of 0 to 6 for the Rankin scale. A high value of the Rankin scale indicates poor recovery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cerebral Infarction and Cerebral Infarction Recovery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 12 Jun 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between D-dimer concentration and NIHSS score (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.