Clinical trial NCT02010892: Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study
Official title: Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thoracic Aortic Aneurysm
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2013-12-13
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being referred to a specialist centre for diagnosis and treatment of their aneurysm

Brief summary: This is a prospective observational cohort study that will collect data from the point of referral through to secondary care, aiming for 3 years median follow-up (range 1-5 years). The data collected will allow estimation of the success of any intervention (in terms of reducing rate of aneurysm growth, rupture or dissection) as well as estimation of the risks associated with the three procedures. Clinical outcomes in the three treatment groups will be described.

Aims

We aim to answer the following questions:

1. Without procedural intervention for chronic thoracic aortic aneurysm (CTAA), what is the risk of aneurysm growth, dissection, rupture, permanent neurological injury or death? What is the effect on quality of life (QoL)?
2. If a patient has endovascular stent grafting (ESG) or open surgical repair (OSR), what is the risk of growth, dissection, rupture, permanent neurological injury or death?
3. How does QoL change from pre- to post intervention?
4. Can aneurysm or patient related predictors of good/poor treatment outcomes be determined?
5. What is the most cost-effective strategy in:

   1. Patients eligible for either ESG or OSR?
   2. Patients eligible for either ESG or best medical therapy (BMT)?
   3. Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?
6. What further research is required? What would be the most important research to pursue?


Eligibility criteria: Inclusion Criteria:

* Thoracic Aortic Aneurysm \> 4cm
* Age ≥18 years
* Able to give informed consent

Exclusion Criteria:

* Intervention required below the level of the coeliac axis
* Acute dissection or malperfusion syndromes (such as myocardial infarction,acute stroke or limb ischaemia)

Primary outcomes:
measure: Aneurysm Growth
timeFrame: 1, 2, 3 , 4 and 5 years post recruitment
measure: Quality of life
timeFrame: 1, 2, 3 , 4 and 5 years post recruitment
measure: Freedom from reintervention
timeFrame: 1, 2, 3 , 4 and 5 years post recruitment
measure: Freedom from death or permanent neurological injury
timeFrame: 1, 2, 3 , 4 and 5 years post recruitment
measure: Costs to the NHS
timeFrame: 1, 2, 3 , 4 and 5 years post recruitment
measure: Incremental cost per quality adjusted life year gained
timeFrame: 1, 2, 3 , 4 and 5 years post recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
state: Cambs
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Stephen Large, FRCS
role: STUDY_CHAIR
References:
citation: Sharples L, Sastry P, Freeman C, Gray J, McCarthy A, Chiu YD, Bicknell C, McMeekin P, Vallabhaneni SR, Cook A, Vale L, Large S. Endovascular stent grafting and open surgical replacement for chronic thoracic aortic aneurysms: a systematic review and prospective cohort study. Health Technol Assess. 2022 Jan;26(6):1-166. doi: 10.3310/ABUT7744.