StatinINSTANTNCT03061487
Influence of Statins in Artery Aneurysms
An observational study of Statin and Aneurysm, run by University of Catanzaro at 1 site in Italy.
Trial summary
The altered balance between the proteinases and their tissue inhibitors (TIMPS) is one of the pathogenetical mechanism of the aneurysmatic connective tissue degeneration. The increasement of protease, collagenase and elastase activity results indeed in a dramatic drop of collagen and elastin tissue and serum… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Statin, Aneurysm, Extracellular Matrix Alteration
- What is being tested?
- Open Surgical Treatment of Aneurysm (Aneurysmectomy)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2017to 27 Apr 2018
- 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 affected by central and peripheral aneurysmal disease are going to be recruited and then divided in two groups based on the dosage of the statin treatment: the first group with maximum statin daily dose ( Atorvastatin 80 mg, Simvastatin 40 mg, Rosuvastatin 40 mg), the second group with minimum statin daily dose. The latter will be defined as the control group.
Who may be able to join
- Patients under statins treatment with pleiotropic effect: Simvastatin, Rosuvastatin, Atorvastatin
- Patients underwent open aneurysm repair
- Age >18
- signing informed consent
Who cannot join
- Patients with chronic diseases such as liver diseases
- Pazient whith malignant diseases
- Recreational drug intake and alcohol abuse
- Intake of statins other than those under study or in combination therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Magna Graecia of Catanzaro
Catanzaro, Catanzaro, 88100
Raffaele Serra, M.D., Ph.D., +3909613647380, rserra@unicz.it
Stefano de Franciscis, M.D.
About this study
Official title: The Influence of Statin Treatment on Aneurysmatic Disease
The altered balance between the proteinases and their tissue inhibitors (TIMPS) is one of the pathogenetical mechanism of the aneurysmatic connective tissue degeneration. The increasement of protease, collagenase and elastase activity results indeed in a dramatic drop of collagen and elastin tissue and serum levels.Matrix Metalloproteinases (MMPs) are a group of proteolytic enzymes that along with their specific and non-specific inhibitors modulate the extracellular matrix composition. Recent studies have suggested an interesting role of microRNAs (miRNAs) in the regulation mechanisms of inflammation.
The aim of our study is to analyse the influence of statin treatment on aneurysmatic disease by monitoring MMPs and miRNAs in aneurysmatic wall tissue and MMps blood levels.
Read the detailed description
The altered balance between the proteinases and their tissue inhibitors (TIMPS) is one of the pathogenetical mechanism of the aneurysmal connective tissue degeneration. The increase of protease, collagenase and elastase activity results indeed in a dramatic drop of collagen and elastin tissue and serum levels.
Vessels wall strength decrease is associated with the blood flow shear stress and affects negatively the walls integrity, causing the aneurysmatic vessel degeneration.
Matrix Metalloproteinases (MMPs) are a group of proteolytic enzymes that along with their specific and non-specific inhibitors modulate the extracellular matrix composition.
So far, 25 MMPs have been discovered, in particular, the ones that will be considered in this study are: MMP-2, MMP-9, and neutrophil gelatinase-associated lipocalin (NGAL) a related protein which is able to control MMP-9 activities.
Inflammation plays a central role in the pathogenetical pathway of aneurysmatic developement. Recent studies have suggested an interesting role of miRNAs in the regulation mechanisms of inflammation. miRNAs are short ribonucleic acid molecules usually composed of 20 to 25 nucleotides that can regulate mRNA transcription and protein translation by targeting the 3'-untranslated regions (3'-UTR) of target genes. miRNAs are involved in various physiological responses and pathological processes. Increasing evidence suggest that miRNAs are involved in inflammatory responses. In particular the ones that will be focused on this study are: miR-29b, miR-21, miR-181a, miR-150.
Very often, patients with aneurysmatic disease are under statin treatment. Some Statins (Atorvastatin, Simvastatin or Rosuvastatin) with pleiotropic effects may also play a protective role by conditioning the progression of the aneurysmatic degeneration.
The aim of our study is to analyse the influence of statin treatment on aneurysmatic disease by monitoring some MMPs and related molecules (MMP-2, MMP-9 and NGAL), miRNAs (the evaluation will be performed in aneurysmatic wall tissues and circulating blood levels).
Patients affected by central and peripheral aneurysmatic disease will be recruited and then divided in two groups based on the dosage of the statin treatment: the first group with maximum statin daily dose (Atorvastatin 80 mg, Simvastatin 40 mg, Rosuvastatin 40 mg), the second group with minimum statin daily dose. The latter will be defined as the control group.
Only patients which will fullfill the criteria to undergo surgical treatment will be recruited in the study in order to collect biological specimen of the aneurysmatic tissues .
The investigation consist in:
- taking a preoperative blood sample to evaluate the MMPs circulating levels
- taking an aneurysmatic vessel wall histological sample with an intraoperative biopsy to evaluate the tissue MMPs and miRNAs levels.
Previously, several studies suggested a role of MMPs (MMP-2 and MMP-9) and miRNAs in regulation of aneurysm developement, in particular miR29b, miR-181a, miR-21, miR-150.
The comparison between MMPs Levels in the study group and in the control group might highlight a role for MMPs level as a marker of aneurysmatic disease progression, consequently allowing the patient's stratification by analysing the risk of aneurysmatic evolution and growth.
- Conditions
- Statin, Aneurysm, Extracellular Matrix Alteration
- Being tested
- Open Surgical Treatment of Aneurysm (Aneurysmectomy)
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Surgical Treatment of Aneurysm (Aneurysmectomy)Procedure or surgery
Aneurysmectomy is a surgical procedure in which a localized, dilated, weakened section of an artery (aneurysm) is removed (resected). The artery is either replaced with a synthetic graft, as seen in an aneurysm in the chest (thoracic aneurysm), abdomen (abdominal aneurysm) or leg (femoral or popliteal aneurysm).
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients affected by central and peripheral aneurismatic disease with maximum statin daily dose ( Atorvastatin 80 mg, Simvastatin 40 mg, Rosuvastatin 40 mg).
Patients will undergo Open Surgical Treatment of Aneurysm (Aneurysmectomy).
The investigation consist in:
* taking a preoperative blood sample to evaluate the MMPs circulating levels
* taking an aneurismatic vassel wall istological sample with an intraoperative biopsy to evaluate the tissue MMPs and miRNAs levels Receives: Procedure: Open Surgical Treatment of Aneurysm (Aneurysmectomy) | |
| Group II | Patients affected by central and peripheral aneurismatic disease with minimum statin daily dose.
Patients will undergo Open Surgical Treatment of Aneurysm (Aneurysmectomy).
The investigation consist in:
* taking a preoperative blood sample to evaluate the MMPs circulating levels
* taking an aneurismatic vassel wall istological sample with an intraoperative biopsy to evaluate the tissue MMPs and miRNAs levels Receives: Procedure: Open Surgical Treatment of Aneurysm (Aneurysmectomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of MMP-2, MMP-9 and NGAL levels in blood and aneurysms tissue
MMP-2, MMP-9 and NGAL will be studied in both groups. Elisa Testing will be used to analyze the blood samples and Western blot analysis will be used for the tissue samples.
Measured: 1 year
Evalutation of miRNAs levels in blood and aneurysms tissue
Evaluation of miRNAs levels (in particular miR29b, miR-181a, miR-21, miR-150) will be studied in both groups. Stem-loop reverse-transcription PCR (RT-qPCR) method will be used for measuring individual microRNAs (miRNAs) in tissue and blood samples.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start15 Feb 2017
- Primary completion26 Feb 2018 (estimated)
- Study completion27 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StatinStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
- Investigators
- Stefano de Franciscis, M.D., Study chair, University Magna Graecia of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061487
- Sponsor's protocol ID
- ER.ALL.2016.04
- Acronym
- INSTANT
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serra R, Grande R, Montemurro R, Butrico L, Calio FG, Mastrangelo D, Scarcello E, Gallelli L, Buffone G, de Franciscis S. The role of matrix metalloproteinases and neutrophil gelatinase-associated lipocalin in central and peripheral arterial aneurysms. Surgery. 2015 Jan;157(1):155-62. doi: 10.1016/j.surg.2014.06.008. Epub 2014 Nov 1.
PubMed 25444221de Franciscis S, Mastroroberto P, Gallelli L, Buffone G, Montemurro R, Serra R. Increased plasma levels of metalloproteinase-9 and neutrophil gelatinase-associated lipocalin in a rare case of multiple artery aneurysm. Ann Vasc Surg. 2013 Nov;27(8):1185.e5-7. doi: 10.1016/j.avsg.2013.01.011. Epub 2013 Aug 26.
PubMed 23988549Serra R, Volpentesta G, Gallelli L, Grande R, Buffone G, Lavano A, de Franciscis S. Metalloproteinase-9 and neutrophil gelatinase-associated lipocalin plasma and tissue levels evaluation in middle cerebral artery aneurysms. Br J Neurosurg. 2014 May 5. doi: 10.3109/02688697.2014.913777. Online ahead of print.
PubMed 24799278Piechota-Polanczyk A, Demyanets S, Mittlboeck M, Hofmann M, Domenig CM, Neumayer C, Wojta J, Klinger M, Nanobachvili J, Huk I. The Influence of Simvastatin on NGAL, Matrix Metalloproteinases and Their Tissue Inhibitors in Human Intraluminal Thrombus and Abdominal Aortic Aneurysm Tissue. Eur J Vasc Endovasc Surg. 2015 May;49(5):549-55. doi: 10.1016/j.ejvs.2015.02.011. Epub 2015 Mar 21.
PubMed 25800096Maegdefessel L, Azuma J, Toh R, Merk DR, Deng A, Chin JT, Raaz U, Schoelmerich AM, Raiesdana A, Leeper NJ, McConnell MV, Dalman RL, Spin JM, Tsao PS. Inhibition of microRNA-29b reduces murine abdominal aortic aneurysm development. J Clin Invest. 2012 Feb;122(2):497-506. doi: 10.1172/JCI61598. Epub 2012 Jan 24.
PubMed 22269326Adam M, Raaz U, Spin JM, Tsao PS. MicroRNAs in Abdominal Aortic Aneurysm. Curr Vasc Pharmacol. 2015;13(3):280-90. doi: 10.2174/15701611113119990015.
PubMed 23713862
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Statin Treatment on Aneurysmatic Disease
- ClinicalTrials.gov ID
- NCT03061487
- Acronym / sponsor ID
- INSTANT / ER.ALL.2016.04
- Conditions
- Statin, Aneurysm, Extracellular Matrix Alteration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 26 Feb 2018 (estimated)
- Study completion
- 27 Apr 2018 (estimated)
- First posted
- 23 Feb 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.
The altered balance between the proteinases and their tissue inhibitors (TIMPS) is one of the pathogenetical mechanism of the aneurysmatic connective tissue degeneration. The increasement of protease, collagenase and elastase activity results indeed in a dramatic drop of collagen and elastin tissue and serum levels.Matrix Metalloproteinases (MMPs) are a group of proteolytic enzymes that along with their specific and non-specific inhibitors modulate the extracellular matrix composition. Recent studies have suggested an interesting role of microRNAs (miRNAs) in the regulation mechanisms of inflammation.
The aim of our study is to analyse the influence of statin treatment on aneurysmatic disease by monitoring MMPs and miRNAs in aneurysmatic wall tissue and MMps blood levels.
Detailed description
The altered balance between the proteinases and their tissue inhibitors (TIMPS) is one of the pathogenetical mechanism of the aneurysmal connective tissue degeneration. The increase of protease, collagenase and elastase activity results indeed in a dramatic drop of collagen and elastin tissue and serum levels.
Vessels wall strength decrease is associated with the blood flow shear stress and affects negatively the walls integrity, causing the aneurysmatic vessel degeneration.
Matrix Metalloproteinases (MMPs) are a group of proteolytic enzymes that along with their specific and non-specific inhibitors modulate the extracellular matrix composition.
So far, 25 MMPs have been discovered, in particular, the ones that will be considered in this study are: MMP-2, MMP-9, and neutrophil gelatinase-associated lipocalin (NGAL) a related protein which is able to control MMP-9 activities.
Inflammation plays a central role in the pathogenetical pathway of aneurysmatic developement. Recent studies have suggested an interesting role of miRNAs in the regulation mechanisms of inflammation. miRNAs are short ribonucleic acid molecules usually composed of 20 to 25 nucleotides that can regulate mRNA transcription and protein translation by targeting the 3'-untranslated regions (3'-UTR) of target genes. miRNAs are involved in various physiological responses and pathological processes. Increasing evidence suggest that miRNAs are involved in inflammatory responses. In particular the ones that will be focused on this study are: miR-29b, miR-21, miR-181a, miR-150.
Very often, patients with aneurysmatic disease are under statin treatment. Some Statins (Atorvastatin, Simvastatin or Rosuvastatin) with pleiotropic effects may also play a protective role by conditioning the progression of the aneurysmatic degeneration.
The aim of our study is to analyse the influence of statin treatment on aneurysmatic disease by monitoring some MMPs and related molecules (MMP-2, MMP-9 and NGAL), miRNAs (the evaluation will be performed in aneurysmatic wall tissues and circulating blood levels).
Patients affected by central and peripheral aneurysmatic disease will be recruited and then divided in two groups based on the dosage of the statin treatment: the first group with maximum statin daily dose (Atorvastatin 80 mg, Simvastatin 40 mg, Rosuvastatin 40 mg), the second group with minimum statin daily dose. The latter will be defined as the control group.
Only patients which will fullfill the criteria to undergo surgical treatment will be recruited in the study in order to collect biological specimen of the aneurysmatic tissues .
The investigation consist in:
- taking a preoperative blood sample to evaluate the MMPs circulating levels
- taking an aneurysmatic vessel wall histological sample with an intraoperative biopsy to evaluate the tissue MMPs and miRNAs levels.
Previously, several studies suggested a role of MMPs (MMP-2 and MMP-9) and miRNAs in regulation of aneurysm developement, in particular miR29b, miR-181a, miR-21, miR-150.
The comparison between MMPs Levels in the study group and in the control group might highlight a role for MMPs level as a marker of aneurysmatic disease progression, consequently allowing the patient's stratification by analysing the risk of aneurysmatic evolution and growth.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Procedure: Open Surgical Treatment of Aneurysm (Aneurysmectomy)Patients affected by central and peripheral aneurismatic disease with maximum statin daily dose ( Atorvastatin 80 mg, Simvastatin 40 mg, Rosuvastatin 40 mg). Patients will undergo Open Surgical Treatment of Aneurysm (Aneurysmectomy). The investigation consist in: * taking a preoperative blood sample to evaluate the MMPs circulating levels * taking an aneurismatic vassel wall istological sample with an intraoperative biopsy to evaluate the tissue MMPs and miRNAs levels |
| Group II | – | Procedure: Open Surgical Treatment of Aneurysm (Aneurysmectomy)Patients affected by central and peripheral aneurismatic disease with minimum statin daily dose. Patients will undergo Open Surgical Treatment of Aneurysm (Aneurysmectomy). The investigation consist in: * taking a preoperative blood sample to evaluate the MMPs circulating levels * taking an aneurismatic vassel wall istological sample with an intraoperative biopsy to evaluate the tissue MMPs and miRNAs levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by central and peripheral aneurysmal disease are going to be recruited and then divided in two groups based on the dosage of the statin treatment: the first group with maximum statin daily dose ( Atorvastatin 80 mg, Simvastatin 40 mg, Rosuvastatin 40 mg), the second group with minimum statin daily dose. The latter will be defined as the control group.
Key inclusion criteria (4 listed)
- Patients under statins treatment with pleiotropic effect: Simvastatin, Rosuvastatin, Atorvastatin
- Patients underwent open aneurysm repair
- Age >18
- signing informed consent
Key exclusion criteria (4 listed)
- Patients with chronic diseases such as liver diseases
- Pazient whith malignant diseases
- Recreational drug intake and alcohol abuse
- Intake of statins other than those under study or in combination therapy
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 |
|---|---|---|
| Open Surgical Treatment of Aneurysm (Aneurysmectomy)Aneurysmectomy is a surgical procedure in which a localized, dilated, weakened section of an artery (aneurysm) is removed (resected). The artery is either replaced with a synthetic graft, as seen in an aneurysm in the chest (thoracic aneurysm), abdomen (abdominal aneurysm) or leg (femoral or popliteal aneurysm). | Procedure or surgery | Group I, Group II |
Primary outcome
Evaluation of MMP-2, MMP-9 and NGAL levels in blood and aneurysms tissue
Time frame: 1 year
MMP-2, MMP-9 and NGAL will be studied in both groups. Elisa Testing will be used to analyze the blood samples and Western blot analysis will be used for the tissue samples.
Evalutation of miRNAs levels in blood and aneurysms tissue
Time frame: 1 year
Evaluation of miRNAs levels (in particular miR29b, miR-181a, miR-21, miR-150) will be studied in both groups. Stem-loop reverse-transcription PCR (RT-qPCR) method will be used for measuring individual microRNAs (miRNAs) in tissue and blood samples.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Background: PubMed 25444221Serra R, Grande R, Montemurro R, Butrico L, Calio FG, Mastrangelo D, Scarcello E, Gallelli L, Buffone G, de Franciscis S. The role of matrix metalloproteinases and neutrophil gelatinase-associated lipocalin in central and peripheral arterial aneurysms. Surgery. 2015 Jan;157(1):155-62. doi: 10.1016/j.surg.2014.06.008. Epub 2014 Nov 1.
- Background: PubMed 23988549de Franciscis S, Mastroroberto P, Gallelli L, Buffone G, Montemurro R, Serra R. Increased plasma levels of metalloproteinase-9 and neutrophil gelatinase-associated lipocalin in a rare case of multiple artery aneurysm. Ann Vasc Surg. 2013 Nov;27(8):1185.e5-7. doi: 10.1016/j.avsg.2013.01.011. Epub 2013 Aug 26.
- Background: PubMed 24799278Serra R, Volpentesta G, Gallelli L, Grande R, Buffone G, Lavano A, de Franciscis S. Metalloproteinase-9 and neutrophil gelatinase-associated lipocalin plasma and tissue levels evaluation in middle cerebral artery aneurysms. Br J Neurosurg. 2014 May 5. doi: 10.3109/02688697.2014.913777. Online ahead of print.
- Background: PubMed 25800096Piechota-Polanczyk A, Demyanets S, Mittlboeck M, Hofmann M, Domenig CM, Neumayer C, Wojta J, Klinger M, Nanobachvili J, Huk I. The Influence of Simvastatin on NGAL, Matrix Metalloproteinases and Their Tissue Inhibitors in Human Intraluminal Thrombus and Abdominal Aortic Aneurysm Tissue. Eur J Vasc Endovasc Surg. 2015 May;49(5):549-55. doi: 10.1016/j.ejvs.2015.02.011. Epub 2015 Mar 21.
- Background: PubMed 22269326Maegdefessel L, Azuma J, Toh R, Merk DR, Deng A, Chin JT, Raaz U, Schoelmerich AM, Raiesdana A, Leeper NJ, McConnell MV, Dalman RL, Spin JM, Tsao PS. Inhibition of microRNA-29b reduces murine abdominal aortic aneurysm development. J Clin Invest. 2012 Feb;122(2):497-506. doi: 10.1172/JCI61598. Epub 2012 Jan 24.
- Background: PubMed 23713862Adam M, Raaz U, Spin JM, Tsao PS. MicroRNAs in Abdominal Aortic Aneurysm. Curr Vasc Pharmacol. 2015;13(3):280-90. doi: 10.2174/15701611113119990015.
- 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.
Stefano de Franciscis, M.D. study chair
University Magna Graecia of Catanzaro
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 Statin and Aneurysm, run by University of Catanzaro at 1 site in Italy.
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 4 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 27 Feb 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 Italy. 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 Raffaele Serra, M.D.; Ph.D. (+39 09613647380, rserra@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of MMP-2, MMP-9 and NGAL levels in blood and aneurysms tissue (time frame: 1 year). The study lists 2 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 NCT03061487, which also lists 6 linked publications.
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 27 Feb 2017.