Abdominal Aortic AneurysmSCANNCT02179801
Screening Cardiovascular Patients for Aortic aNeurysms (SCAN)
An observational study of Abdominal Aortic Aneurysm and AAA, run by Technical University of Munich at 2 sites in Germany.
Trial summary
The aim of the cohort study SCAN (Screening Cardiovascular patients for Aortic aNeurysms) is to establish a screening programm for patients with a high risk for an AAA. Aortic aneurysms in these patients should be identified at an early stage and thereby AAA-associated mortality be decreased. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Abdominal Aortic Aneurysm, AAA
- How many people
- 1,000 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2014to 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men with coronary artery intervention (PTCA/stenting) and at least 1 risk factor for AAA (hypertension, hyperlipidaemia, hyperuricemia, nicotine abuse,positive family history.
Who may be able to join
- men with coronary artery intervention (PTCA/stenting)
- at least 1 risk factor for AAA (hypertension, hyperlipidaemia, hyperuricemia, nicotine abuse,positive family history)
Who cannot join
- life expectancy less than 1 year
- inability to follow the instructions of the investigator (dementia, lack of time, insufficient understanding of the language)
- insufficient compliance
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
I. Medizinischen Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München
München, Bavaria, 81675
Karl-Ludwig Laugwitz, Univ.-Prof.Dr.med., +49 (0) 89 4140 ext. 2350, sekretariat-laugwitz@tum.de
Karl-Ludwig Laugwitz, Univ.-Prof.Dr.med.
- Recruiting
Klinikum rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie
Munich, Bavaria, 81675
Hans-Henning Eckstein, Univ.-Prof.Dr.med., 0049894140 ext. 2167, gefaesschirurgie@lrz.tum.de
Benedikt Reutersberg, Dr. med., 0049894140 ext. 2166, gefaesschirurgie@lrz.tum.de
About this study
The aim of the cohort study SCAN (Screening Cardiovascular patients for Aortic aNeurysms) is to establish a screening programm for patients with a high risk for an AAA. Aortic aneurysms in these patients should be identified at an early stage and thereby AAA-associated mortality be decreased.
Read the detailed description
A recently published meta-analysis showed a higher prevalence of aortic aneurysm (AAA) in men requiring treatment of coronary heart disaese compared to standard population. In women, however, the prevalence was not increased. Thus, the SCAN project addresses male patients who underwent coronary artery intervention in order to screen them for the presence of an AAA using duplex sonography.
The SCAN project involves the following elements:
- Informing the patient with cardiovascular risk factors about the clinical picture of AAA
- An ultrasound scan of the abdominal aorta in patients with an increased risk for AAA
- Acquisition of patient data followed by a correlation analysis for the parameters presence of AAA and cardiovascular diseases
The cohort study is part of the SCAN project which is also conducted in an similar way by Catharina Ziekenhuis Eindhoven ClinicalTrials.gov Identifier:NCT01643317.
- Conditions
- Abdominal Aortic Aneurysm, AAA
- Keywords
- Abdominal aortic aneurysm, AAA, Screening
- Medical subject headings
- Aortic Aneurysm, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of AAA
Ultrasound screen for the presence of an AAA
Measured: 1 year
Secondary outcomes (4)
Prevalence of AAA in the cohort requiring treatment
Measuring the AAA diameter
Measured: 1 year
Correlation of risk factors for AAA with risk factors for coronary artery disease
Therefore the cardiovascular risk factors ( diabetes, hypertension, hyperlipidaemia, hyperuricemia, nicotine abuse, positive family history, obesity) will be requested.
Measured: 1 year
Distribution of risk factors
Distribution of cardiovascular risk factors (diabetes, hypertension, hyperlipidaemia, hyperuricemia, nicotine abuse, positive family history, obesity) between patients with an without an AAA
Measured: 1 year
Correlation of the number of treated vessels and AAA
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 posted2 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies 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
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ.-Prof. Dr. med. Hans-Henning Eckstein, Technical University of Munich
- Investigators
- Hans-Henning Eckstein, Univ.-Prof.Dr.med., Principal investigator, Department for Vascular and Endovascular Surgery, Klinikum rechts der Isar der Technische Universität MünchenKarl-Ludwig Laugwitz, Univ.-Prof.Dr.med., Principal investigator, I. Medizinischen Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179801
- Sponsor's protocol ID
- GES_SCAN
- Acronym
- SCAN
- Status last verified
- Jan 2017
- First submitted
- 12 Jun 2014
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Cardiovascular Patients for Aortic aNeurysms (SCAN)
- ClinicalTrials.gov ID
- NCT02179801
- Acronym / sponsor ID
- SCAN / GES_SCAN
- Conditions
- Abdominal Aortic Aneurysm, AAA
- Keywords
- Abdominal aortic aneurysm, AAA, Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 2 Jul 2014 (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.
The aim of the cohort study SCAN (Screening Cardiovascular patients for Aortic aNeurysms) is to establish a screening programm for patients with a high risk for an AAA. Aortic aneurysms in these patients should be identified at an early stage and thereby AAA-associated mortality be decreased.
Detailed description
A recently published meta-analysis showed a higher prevalence of aortic aneurysm (AAA) in men requiring treatment of coronary heart disaese compared to standard population. In women, however, the prevalence was not increased. Thus, the SCAN project addresses male patients who underwent coronary artery intervention in order to screen them for the presence of an AAA using duplex sonography.
The SCAN project involves the following elements:
- Informing the patient with cardiovascular risk factors about the clinical picture of AAA
- An ultrasound scan of the abdominal aorta in patients with an increased risk for AAA
- Acquisition of patient data followed by a correlation analysis for the parameters presence of AAA and cardiovascular diseases
The cohort study is part of the SCAN project which is also conducted in an similar way by Catharina Ziekenhuis Eindhoven ClinicalTrials.gov Identifier:NCT01643317.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men with coronary artery intervention (PTCA/stenting) and at least 1 risk factor for AAA (hypertension, hyperlipidaemia, hyperuricemia, nicotine abuse,positive family history.
Key inclusion criteria (2 listed)
- men with coronary artery intervention (PTCA/stenting)
- at least 1 risk factor for AAA (hypertension, hyperlipidaemia, hyperuricemia, nicotine abuse,positive family history)
Key exclusion criteria (3 listed)
- life expectancy less than 1 year
- inability to follow the instructions of the investigator (dementia, lack of time, insufficient understanding of the language)
- insufficient compliance
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
Prevalence of AAA
Time frame: 1 year
Ultrasound screen for the presence of an AAA
4 secondary outcomes
Prevalence of AAA in the cohort requiring treatment
Time frame: 1 year
Correlation of risk factors for AAA with risk factors for coronary artery disease
Time frame: 1 year
Distribution of risk factors
Time frame: 1 year
Correlation of the number of treated vessels and AAA
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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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.
Hans-Henning Eckstein, Univ.-Prof.Dr.med. principal investigator
Department for Vascular and Endovascular Surgery, Klinikum rechts der Isar der Technische Universität München
Karl-Ludwig Laugwitz, Univ.-Prof.Dr.med. principal investigator
I. Medizinischen Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München
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 Abdominal Aortic Aneurysm and AAA, run by Technical University of Munich 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 2 inclusion and 3 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 6 Jan 2017. 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-Henning Eckstein, Univ.-Prof.Dr.med. (0049894140 ext. 2167, gefaesschirurgie@lrz.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of AAA (time frame: 1 year). 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 6 Jan 2017.