Screening Cardiovascular Patients for Aortic aNeurysms (SCAN)

Abdominal Aortic Aneurysm Clinical Trial

— SCAN  

Official title:

Screening Cardiovascular Patients for Aortic aNeurysms (SCAN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02179801
• Other study ID #: GES_SCAN
• Status: Recruiting
• Phase: N/A
• First received: June 12, 2014
• Last updated: January 5, 2017
• Start date: March 2014
• Est. completion date: April 2018

Study information

• Verified date: January 2017
• Source: Technische Universität München
• Contact: Hans-Henning Eckstein, Univ.-Prof.Dr.med.
• Phone: 0049894140
• Email: gefaesschirurgie[@]lrz.tum.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• AAA
• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
Germany	I. Medizinischen Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München	München	Bayern
Germany	Klinikum rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie	Munich	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	I. Medizinischen Klinik und Poliklinik, Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of AAA	Ultrasound screen for the presence of an AAA	1 year	No
Secondary	Prevalence of AAA in the cohort requiring treatment	Measuring the AAA diameter	1 year	No
Secondary	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.	1 year	No
Secondary	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	1 year	No
Secondary	Correlation of the number of treated vessels and AAA		1 year	No

External Links

•   Homepage of the Department for Vascular and Endovascular Surgery