Clinical trial NCT02179801: Screening Cardiovascular Patients for Aortic aNeurysms (SCAN)
Official title: Screening Cardiovascular Patients for Aortic aNeurysms (SCAN)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Aortic Aneurysm
AAA
Keywords: Abdominal aortic aneurysm
AAA
Screening
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: I. Medizinischen Klinik und Poliklinik, Technical University of Munich
First posted: 2014-07-02
Enrollment: 1000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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:

1. Informing the patient with cardiovascular risk factors about the clinical picture of AAA
2. An ultrasound scan of the abdominal aorta in patients with an increased risk for AAA
3. 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.

Eligibility criteria: Inclusion Criteria:

* men with coronary artery intervention (PTCA/stenting)
* at least 1 risk factor for AAA (hypertension, hyperlipidaemia, hyperuricemia, nicotine abuse,positive family history)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prevalence of AAA
timeFrame: 1 year
Secondary outcomes:
measure: Prevalence of AAA in the cohort requiring treatment
timeFrame: 1 year
measure: Correlation of risk factors for AAA with risk factors for coronary artery disease
timeFrame: 1 year
measure: Distribution of risk factors
timeFrame: 1 year
measure: Correlation of the number of treated vessels and AAA
timeFrame: 1 year
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie
state: Bayern
city: München
country: Germany
facility: I. Medizinischen Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München
state: Bayern
Study officials:
affiliation: Department for Vascular and Endovascular Surgery, Klinikum rechts der Isar der Technische Universität München
name: Hans-Henning Eckstein, Univ.-Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
affiliation: I. Medizinischen Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München
name: Karl-Ludwig Laugwitz, Univ.-Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: