StrokeNCT01126775
Neuro-Prävention im Rahmen Des Interventionsprojektes INVADE-2 (Follow-up Studie)
An observational study of Stroke and Dementia, run by INVADE gGmbH at 2 sites in Germany.
Trial summary
"Silent" strokes are more frequent than clinical apparent strokes and can be detected noninvasively by MRI-investigations of the brain. Persons with silent strokes have a considerably increased risk for clinical apparent strokes as well as for the development of dementia. Read more about this study
- Who is it for?
- Ages 55 years and older
- How many people
- 1,000 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2012to Nov 2013
- 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 55 years and older
- All sexes
- Adult, Older adult
Study population: 1000 participants of INVADE-2-study ("Intervention project on cerebrovascular diseases and dementia in the district of Ebersberg, Bavaria")
Who may be able to join
- signed informed consent for NPV-2
- ongoing participation in INVADE-2
- completed participation in Neuroprävention study (NPV-1)
Who cannot join
- not completed Neuroprävention study (Drop-out)
- disagreement of notification of incidental findings
- lack of capacity to consent of study participant
- lack of willingness to cooperate of study participant
Trial locations and contacts
2 sites in 1 country.
Hans Gnahn, Dr. contact
Astrid Biermeier contact
Germany2 sites, 2 recruiting
- Recruiting
Praxis Dr. Briesenick u. Dr. Förstner
Baldham, Bavaria, D-85598
Claus Briesenick, Dr., +49 (0)8106 ext. 308866, praxis@neuro-baldham.de
Sabine Förstner, Dr., +49 (0)8106 ext. 308866, praxis@neuro-baldham.de
- Recruiting
Praxis Dr. Gnahn u. Dr. Klein
Ebersberg, Bavaria, 85560
Hans Gnahn, Dr., hans@gnahn.de
Julia Hartmann, Dr., hartmann@invade.de
About this study
Official title: Neuro-Prävention im Rahmen Des Interventionsprojektes INVADE-2 Systematische Prävention Bei Hochrisikopatienten für Schlaganfall Und vaskulär (Mit)Bedingte Demenz: Identifizierung Und Behandlung Von Stummen Hirninfarkten.
"Silent" strokes are more frequent than clinical apparent strokes and can be detected noninvasively by MRI-investigations of the brain. Persons with silent strokes have a considerably increased risk for clinical apparent strokes as well as for the development of dementia. Intention of the study is the detection of silent strokes and microbleedings by standardized cranial MRI in 1000 participants (500 high-risk and 500 low-risk persons for cerebrovascular accidents) after a standardized neurological and neuropsychological examination. Results will be the base of early detection and early preventive strategies of cerebrovascular accidents in high-risk persons.
In the course of a systematic follow-up examination without MRI the same 1000 patients (500 high-risk and 500 low-risk persons for cerebrovascular accidents) will be reinvited to the sites. In addition to the standardized neurological and neuropsychological examinations a surrogate parameter of nephropathy, microalbumin, will be examined as this parameter could be helpful in forecasting cerebral microangiopathy. The clinical investigation will be expanded by several tests in order to assess symptoms of cerebral microangiopathy.
- Keywords
- Systematic prevention, stroke, vascular dementia, silent strokes, cerebral microangiopathy.
- Medical subject headings
- Stroke, Dementia, Dementia, Vascular, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group non-high-risk | Not described | |
| group high risk | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
In the group of high-risk persons the percentage of silent strokes detected by MRI of the brain is significantly higher than in the group of non-high-risk persons.
Measured: 4/2012 until 11/2013
Secondary outcomes (2)
Detection of silent strokes by MRI in more than 10% of all subjects and diagnostic and therapeutic procedures refinancable near-term and in relation to long-term-consequences
Measured: 4/2012 until 11/2013
Detection of microbleedings by MRI in more than 10% of all subjects
Measured: 4/2010 until 11/2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startApr 2012
- Primary completionNov 2013 (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 StrokeStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- INVADE gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126775
- Sponsor's protocol ID
- INV-1006-Gna-1000-I
- Status last verified
- Jan 2013
- First submitted
- 18 May 2010
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Scherpinski U, Bickel H, Gnahn H, Forstl H, Conrad B, Sander D. [Intervention project on cerebrovascular diseases and dementia in the Ebersberg district (INVADE): rationale and design]. Nervenarzt. 2002 Dec;73(12):1199-204. doi: 10.1007/s00115-002-1443-8. German.
PubMed 12486573
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-Prävention im Rahmen Des Interventionsprojektes INVADE-2 Systematische Prävention Bei Hochrisikopatienten für Schlaganfall Und vaskulär (Mit)Bedingte Demenz: Identifizierung Und Behandlung Von Stummen Hirninfarkten.
- ClinicalTrials.gov ID
- NCT01126775
- Acronym / sponsor ID
- INV-1006-Gna-1000-I
- Keywords
- Systematic prevention, stroke, vascular dementia, silent strokes, cerebral microangiopathy.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- INVADE gGmbHUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Nov 2013 (estimated)
- First posted
- 20 May 2010 (estimated)
- 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.
"Silent" strokes are more frequent than clinical apparent strokes and can be detected noninvasively by MRI-investigations of the brain. Persons with silent strokes have a considerably increased risk for clinical apparent strokes as well as for the development of dementia. Intention of the study is the detection of silent strokes and microbleedings by standardized cranial MRI in 1000 participants (500 high-risk and 500 low-risk persons for cerebrovascular accidents) after a standardized neurological and neuropsychological examination. Results will be the base of early detection and early preventive strategies of cerebrovascular accidents in high-risk persons.
In the course of a systematic follow-up examination without MRI the same 1000 patients (500 high-risk and 500 low-risk persons for cerebrovascular accidents) will be reinvited to the sites. In addition to the standardized neurological and neuropsychological examinations a surrogate parameter of nephropathy, microalbumin, will be examined as this parameter could be helpful in forecasting cerebral microangiopathy. The clinical investigation will be expanded by several tests in order to assess symptoms of cerebral microangiopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group non-high-risk | – | – |
| group high risk | – | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1000 participants of INVADE-2-study ("Intervention project on cerebrovascular diseases and dementia in the district of Ebersberg, Bavaria")
Key inclusion criteria (3 listed)
- signed informed consent for NPV-2
- ongoing participation in INVADE-2
- completed participation in Neuroprävention study (NPV-1)
Key exclusion criteria (4 listed)
- not completed Neuroprävention study (Drop-out)
- disagreement of notification of incidental findings
- lack of capacity to consent of study participant
- lack of willingness to cooperate of study participant
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
In the group of high-risk persons the percentage of silent strokes detected by MRI of the brain is significantly higher than in the group of non-high-risk persons.
Time frame: 4/2012 until 11/2013
2 secondary outcomes
Detection of silent strokes by MRI in more than 10% of all subjects and diagnostic and therapeutic procedures refinancable near-term and in relation to long-term-consequences
Time frame: 4/2012 until 11/2013
Detection of microbleedings by MRI in more than 10% of all subjects
Time frame: 4/2010 until 11/2011
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Background: PubMed 12486573Scherpinski U, Bickel H, Gnahn H, Forstl H, Conrad B, Sander D. [Intervention project on cerebrovascular diseases and dementia in the Ebersberg district (INVADE): rationale and design]. Nervenarzt. 2002 Dec;73(12):1199-204. doi: 10.1007/s00115-002-1443-8. German.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Hans Gnahn, Dr. contact
Astrid Biermeier contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Dementia, run by INVADE gGmbH at 2 sites in Germany.
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 4 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Hans Gnahn, Dr. (hans@gnahn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In the group of high-risk persons the percentage of silent strokes detected by MRI of the brain is significantly higher than in the group of non-high-risk persons. (time frame: 4/2012 until 11/2013). 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 NCT01126775, 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 23 Jan 2013.