Lesional and perilesional damage and recovery of the brain after acute ischemic stroke rated by combined 1H- and 31P-Spectroscopy
Organizational Data
- DRKS-ID:
- DRKS00032960
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2023-12-28
- Last update in DRKS:
- 2023-12-28
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
In this study, the processes involved in the recovery of brain tissue damaged by a stroke, and particularly the surrounding tissue, are intended to be better understood by analyzing changes in pH and metabolic products. This understanding is relevant for identifying potential targets for effective therapies in the subacute and chronic phases of ischemic stroke, which do not currently exist. To analyze metabolic products, MR spectroscopy will be performed on days 1-3 after an ischemic stroke and again at 8 weeks post-stroke. Approximately 30 patients will participate in the study. The study is planned to run from March 2024 to March 2025. There will be only one cohort, and the values obtained from the affected side will be compared with the healthy side of the same patient.
Health condition or problem studied
- Free text:
- acute ischemic stroke
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Patients are examined in the subacute stage (1-3 days after an acute stroke) and in the chronic stage (8 weeks after an acute stroke) using MR spectroscopy. The spectroscopic measurements in and around the ischemic lesion are compared with the healthy side of the respective patient.
Endpoints
- Primary outcome:
- WHAT: This is an exploratory study aimed at analyzing the metabolic processes in damaged brain and surrounding tissue over time. Therefore, multiple spectroscopically measurable parameters are collected (1H spectroscopy: lactate, NAA, glutamine, glutamate, GABA, myoinositol, creatine, choline. 31P spectroscopy: ATP, phosphocreatine, inorganic phosphate, pH, choline, and ethanolamine-containing cell membrane metabolites). WHEN: 1-3 days and 8 weeks after acute ischemic stroke. HOW: MR spectroscopy.
- Secondary outcome:
- WHAT: Clinical symptoms. WHEN: 1-3 days and 8 weeks after acute ischemic stroke. HOW: Physical examination with assessment of the NIHSS.
Study Design
- Purpose:
- Basic research/physiological study
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsklinikum der Goethe-Universität Frankfurt am Main. Frankfurt
Recruitment period and number of participants
- Planned study start date:
- 2024-03-01
- Actual study start date:
- No Entry
- Planned study completion date:
- 2025-03-01
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 30
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Subacute ischemic stroke (maximum 1-3 days after acute event) - demarcated lesion in imaging (DWI, T2w) - Voluntary participation after being informed of the benefits and risks of the examination - Written consent of the subject
Exclusion Criteria
- Reduced general condition that does not allow for an examination duration of approximately 45 minutes - Pregnancy Implanted electronic devices that do not allow measurement within or in the presence of a magnetic field. This includes implanted pacemakers, neurostimulators, drug pumps, and cochlear implants. - Magnetizable metal objects within the body (e.g., shards, clips, or staples from surgeries before 1990, metal fragments in the body, such as those acquired from working in the metalworking industry) - claustrophobia
Addresses
Primary Sponsor
- Address:
- Klinikum der Goethe-Universität Frankfurt am Main, Institut für NeuroradiologieSchleusenweg 2-1660528 FrankfurtGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinikum der Goethe-Universität FrankfurtDr. med. Leonhard MannSchleusenweg 2-1660528 FrankfurtGermany
- Telephone:
- +49-69-6301-5462
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Klinikum der Goethe-Universität FrankfurtDr. med. Leonhard MannSchleusenweg 2-1660528 FrankfurtGermany
- Telephone:
- +49-69-6301-5462
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum der Goethe-Universität Frankfurt, Insitut für NeuroradiologieProf. Dr. med. Elke HattingenSchleusenweg 2-1660528 FrankfurtGermany
- Telephone:
- +49-69-6301-5462
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinikum der Goethe-Universität Frankfurt, Insitut für Neuroradiologie60328 FrankfurtGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission des Fachbereichs Medizin, Universitätsklinikum der Goethe-UniversitätTheodor-Stern-Kai 7, Haus 1, 2. OG, Zimmer 207-21160590 Frankfurt/MainGermany
- Telephone:
- +49-69-63013758
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de/ueber-uns/vorstand-des-universitaetsklinikums/dekan/ethikkommission
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-06-09
- Ethics committee number:
- 2023-1337
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-12-07
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- This monocentric study collects data that will be exclusively analyzed for this study. There are no plans to share the data with other researchers.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry