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Subarachnoid Hemorrhage, AneurysmalRAPIDNCT04613427

Predictors of Rupture Risk of Intracranial Aneurysms

An observational study of Subarachnoid Hemorrhage, Aneurysmal and Intracranial Aneurysm, run by University of Bergen at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients admitted to Haukeland University Hospital with either UIA or aSAH underwent a measurement of bioelectrical impedance and body mass composition using InBody 10. Lipids and lipoproteins were collected from plasma. 60 patients in total were included in the study. Read more about this study

Who is it for?
Ages 18 years and older
How many people
60 participants
Where
1 siteNorway
Study dates
1 Apr 2018to 21 Jun 2019
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: Patients admitted to Haukeland University Hospital with either aneurysmal subarachnoid hemorrhage or unruptured intracranial aneurysm.

Who may be able to join

  • Admitted electively for treatment of unruptured intracranial aneurysm
  • Admitted acutely for aneurysmal subarachnoid hemorrhage
  • Informed consent form signed by patient or close relative

Who cannot join

  • Pregnant
  • Pacemaker
  • Subarachnoid hemorrhage without identified aneurysmal rupture
  • Unruptured aneurysm with previous SAH/intracranial hemorrhage

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • University of Bergen

    Bergen, Hordaland, 5021

Other trials in Norway

About this study

Official title: Predictors of Rupture Risk of Intracranial Aneurysms - Impact of Lipid Metabolism and Mitochondrial Function

Patients admitted to Haukeland University Hospital with either UIA or aSAH underwent a measurement of bioelectrical impedance and body mass composition using InBody 10. Lipids and lipoproteins were collected from plasma. 60 patients in total were included in the study.

Read the detailed description

Subarachnoid hemorrhage (SAH) is a condition mainly caused by the rupture of intracranial aneurysms. The estimated prevalence of intracranial aneurysms in the general population is 1-2%, with an annual incidence of aneurysm rupture causing subarachnoid hemorrhage estimated around 1% in Norway. The mortality rates for aneurysmal subarachnoid hemorrhage (aSAH) are as high as 35%, and for the survivors the condition represents a significant morbidity with long-term cognitive impairment and other challenges. With a mean age of 51-55 years at presentation, the burden, both for the patients themselves and on health care resources, is substantial.

Thus, the risk assessment and management of patients with unruptured intracranial aneurysms (UIA) represents a substantial challenge. The number of patients with incidentally discovered cerebral aneurysms is rapidly growing with the increasing use of non-invasive intracranial magnetic resonance imaging (MRI). Therapy options are endovascular coiling, neurosurgical clipping, or observation. To decide whether to perform a potentially harmful prophylactic procedure or not, better tools to predict the risk of rupture in the given individual are required.

Some risk factors, both for the development of an intracranial aneurysm and for the rupture leading to hemorrhage are identified, such as hypertension, age and smoking. Recent research has shown that obesity and hypercholesterolemia is surprisingly associated with an apparent lower risk of aSAH. However, underlying body composition and dyslipidemic patterns has not yet been explored. Increased knowledge of predictors for aneurysm rupture is required, both to improve the patient care and the decision-making concerning the neurosurgical prevention of aSAH.

In the RAPID project, the investigators aim to identify potential new risk factors for the rupture of intracranial aneurysms by comparing the lipid and lipoprotein profile and the body mass composition in patients with UIA and aSAH.

Direct-segmental multisegmental bioimpedance analysis (DSM-BIA) is a valid tool for the assessment of total body and segmental composition and has shown excellent agreements when compared with dual energy X-ray absorptiometry (DEXA). Body composition will be analysed within day 2 after intervention or surgery using a DSM-BIA scanner (InBody S10, BioSpace Ltd, Seoul, South Korea).

Lipids will be measured enzymatically in ethylenediaminetetraacetic acid (EDTA) plasma/serum on a Hitachi 917 system (Roche Diagnostics GmbH, Mannheim, Germany) using the triacylglycerol (GPO-PAP), cholesterol (CHOD-PAP), HDL-cholesterol plus and LDL-cholesterol plus kit from Roche Diagnostics, and the non-esterifies fatty acid (NEFA FD) kit and the phospholipids kit (Phospholipids FS) from "DiaSys Diagnostic Systems GmbH" (Holzheim, Germany). Glucose will be measured in EDTA-plasma using the Gluco-quant Glucose/HK (GLU) kit from Roche. The total fatty acid composition in EDTA-plasma will be analysed using gas chromatography/mass spectrometry (GC/MS).

Lipoprotein particle size analysis will be performed by proton nuclear magnetic resonance (NMR) spectroscopy. Particle concentrations of lipoproteins of different sizes will be calculated from the measured amplitudes of their spectroscopically lipid methyl group NMR signals. Lipoprotein particle size will be derived from the sum of diameter of each subclass multiplied by its relative mass percentage based on the amplitude of its methyl NMR signal. Particle size analysis will be performed by the Norwegian University of Science and Technology (NTNU).

Medical subject headings
Subarachnoid Hemorrhage, Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04613427
Study groupRoleWhat they receive
Unruptured intracranial aneurysmPatients admitted at Haukeland University Hospital in the study period for treatment of UIA.
Aneurysmal subarachnoid hemorrhagePatients admitted at Haukeland University Hospital in the study period for treatment of aSAH.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anthropometric risk factors of ruptured versus unruptured intracranial aneurysms

    The case group with SAH patients will be compared to the control group with UIA patients.

    The anthropometric variables is measured by InBody S10 and includes BMI, waist circumference, visceral fat area, body fat mass, body fat percentage, fat free mass, and skeletal muscle mass. The waist/height ratio will be calculated.

    The data will be analyzed by generalized linear modeling (logistic regression), and the models will be controlled for prognostic factors, including sex, age, hypertension, smoking, alcoholism, statin use, family history of SAH, aneurysm size, diabetes, and cardiovascular disease.

    Measured: The anthropometric data will be collected within 96 hours after admittance, as well as information on the predictors and risk factors from the patient journal.

Secondary outcomes (5)
  1. Standard lipid risk factors of ruptured versus unruptured intracranial aneurysms

    The lipid risk factors include levels of triacylglycerols (TAGs), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) which will be measured in plasma (mmol/L) non-fasting. From these values, we will calculate the levels of non-HDL-C (TC minus HDL-C) and triacylglycerol-rich lipoprotein cholesterol (TRL-C; non-HDL-C minus LDL-C).

    Measured: Blood samples collection within 96 hours after admittance. Calculations will be performed within 3 years after study completion (June 2022).

  2. Lipid ratios as risk factors of ruptured versus unruptured intracranial aneurysms

    the ratios TAGs/HDL-C, TC/HDL-C, LDL-C/HDL-C and non-HDL-C/HDL-C will be calculated from measured levels.

    Measured: The calculations will be performed prior to statistical analyses within 3 years after study completion (June 2022).

  3. Apolipoprotein risk factors of ruptured versus unruptured intracranial aneurysms

    Apolipoprotein A1 and B levels will be measured in serum non-fasting.

    Measured: Blood samples collection within 96 hours after admittance.

  4. Apolipoprotein A1/B ratio as a risk factor of ruptured versus unruptured intracranial aneurysms

    The ratio Apo-A1/Apo-B will be calculated from measured levels.

    Measured: Calculations will be performed within 3 years after study completion (June 2022).

  5. Lipoprotein subclass risk factors of ruptured versus unruptured intracranial aneurysms.

    Particle concentrations (nmol/L) of different lipoprotein subclasses (large, medium-sized and small very low-density lipoprotein (VLDL), intermediate density lipoprotein (IDL), LDL and HDL particles) will be measured in plasma by using proton nuclear magnetic resonance (NMR) spectroscopy.

    Measured: Blood samples collection within 96 hours after admittance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2020
  2. Study start1 Apr 2018
  3. Primary completion21 Jun 2019
  4. Study completion21 Jun 2019

Resources

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-control
Time perspective
Prospective
Enrolment
60 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04613427
Sponsor's protocol ID
RAPID
Acronym
RAPID
Status last verified
Sep 2020
First submitted
4 Sep 2020
Last updated
3 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lovik K, Laupsa-Borge J, Logallo N, Helland CA. Body composition and rupture risk of intracranial aneurysms. Eur J Med Res. 2024 May 24;29(1):297. doi: 10.1186/s40001-024-01888-3.

    PubMed 38790007

Questions about this trial

What is this clinical trial studying?

An observational study of Subarachnoid Hemorrhage, Aneurysmal and Intracranial Aneurysm, run by University of Bergen at 1 site in Norway.

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: finished, as of the sponsor's last update on 3 Nov 2020. 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 Norway. 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?

Anthropometric risk factors of ruptured versus unruptured intracranial aneurysms (time frame: The anthropometric data will be collected within 96 hours after admittance, as well as information on the predictors and risk factors from the patient journal.). 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 NCT04613427, 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 3 Nov 2020.

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