Abdominal aortic aneurysm screening by ultrasonography in primary care

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN10945166
• Date of registration: 30/03/2015
• Prospective Registration: No
• Primary sponsor: EOXI Vigo
• Public title: Abdominal aortic aneurysm screening by ultrasonography in primary care
• Scientific title: Abdominal aortic aneurysm screening by ultrasonography in primary care: a community screening trial
• Date of first enrolment: 01/01/2015
• Target sample size: 3348
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN10945166
• Study type: Interventional
• Study design: Pragmatic community screening trial. (Screening)

Countries of recruitment

Spain

Contacts

• Name: Ana Clavería

Key inclusion & exclusion criteria

Inclusion criteria: The setting will be the Integrated Management Area of Vigo, which has 583,124 habitants, 23 PC departments and 42 health centres. 21 family doctors (FD) belonging to 14 PC departments in the Vigo area, trained in abdominal ultrasonography and with ultrasound equipment at their health centre, will form the research team’s clinical group. The availability of ultrasound equipment in the centres is part of the portfolio of primary care services of the Vigo area (equipment that is currently available in 11 of the 23 PC departments) and was selected based on the specific training in ultrasonography of any of the family doctors of this centre and their availability to undertake this activity for the whole team.

Intervention cohort:
1. Men aged 65 to 74 years The participating patients will sign the informed consent to participate in the study. Patients who choose not to participate or who do not sign the informed consent will be considered losses. The exclusion criteria refer exclusively to age and sex, bedridden/immobilised patients or those with a previously diagnosed aneurysm.

2. The control cohort will consist of patients of the same sex and age belonging to the remaining quotas of the Vigo area. The patients’ data will be extracted anonymously from the administrative databases of SERGAS and therefore do not require informed consent.

Exclusion criteria: 1. Women
2. <65 or >74
3. Terminally ill
4. Immobilized
5. Previous AAA diagnosed or repaired.

Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Abdominal aortic aneurysm (AAA)
Circulatory System
Abdominal aortic aneurysm, without mention of rupture

Intervention(s)

Intervention cohort: all men aged 65 to 74, attended by each of family physician (FP) researchers.

Recruitment: Each FP researcher (clinical group) provides a list of patients in the age and sex group to the methodological research team group. The administrative area of the health center and / or health care professional project support sent a letter signed by the family physician informing the patient of the study and requesting their participation invitation. Electronic medical records will be reviewed in collaboration with the Teaching Unit of Family and Community Medicine of Vigo and practitioners themselves. Patients will be referred for ultrasound and consultation with their FP. Those who do not answer after a second contact by mail will be considered losses (age, sex and health center shall be recorded).

First consultation: The FP conducted the initial consultation, including informing the patient and answering questions, written informed consent by the patient, filling webpage data collection with the variables included in the study, conduct ultrasound scans and previews that are not recorded in the electronic medical record (EMR) and quote for analytical extraction if it lacks in the previous 6 months. The results will be communicated to the patient and the treatment of their disease and / or risk factors will be adjusted according to clinical guidelines.

To visualize the aorta, the transducer is placed longitudinally just above and slightly to the left of the umbilicus. The maximum transverse diameter in the transverse plane and the anterior-posterior diameter maximum in the longitudinal direction will be measured. Two readings are made and the highest value is registered in. The researcher recorded the data of the patients included in the study in an electronic linked to a web page created for this purpose. This NDC contains software filters that act as a first quality control of recorded data. It was also recorded in the EMR in a note associated wi

Primary Outcome(s)

At 31/12/2020, the impact of early diagnosis in reducing overall mortality, cardiovascular mortality and incidental AAA will be evaluated. To this end, information will be requested relative to the intervention and control cohorts from the Death Registry and at the Galician Health Service: Deaths (by all causes and by cardiovascular causes) and patients detected by incidental hospital diagnosis (hospitalisation and/or emergency surgery for AAA). The specific mortality due to AAA will not be considered due to its low sensitivity.

Secondary Outcome(s)

1. Cardiovascular mortality
2. Surgery for AAA (type of surgery, scheduled/emergency)
3. Type of discharge from hospital

Secondary ID(s)

N/A

Source(s) of Monetary Support

Red Española de Atención Primaria (Spanish Research Network)