Aneurysm care trial - cardiac rehabilitation after aneurysm repair

Pilot randomised controlled trial of cardiac rehabilitation vs standard care after aortic aneurysm repair to reduce adverse cardiovascular events

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN65746249

Enrollment

Registered

2014-06-05

Start date

2014-04-01

Completion date

Unknown

Last updated

2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular disease

Interventions

Cardiac Rehabilitation: Patients undergoing elective aortic aneurysm surgery will be randomised. The 'intervention' limb will enter into a cardiac rehabilitation programme surgery. Car

this will mean standard surgical follow-up and routine primary care management post surgery. Follow-up length: 6 month(s)

study entry: registration and one or more randomisations

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who undergo elective repair of a thoracic or abdominal aortic aneurysm at St George`s Vascular Institute or Leicester Royal Infirmary and are discharged alive from hospital during the study recruitment period will be eligible for entry

Exclusion criteria

Exclusion criteria: 1. Under age 50 2. Unable or unwilling to consent 3. Deemed not medically fit enough for rehab programme by lead CR nurse 4. Unwilling or unable to attend the CR sessions 5. Anyone undergoing expedited or emergent surgical intervention for ruptured or symptomatic aortic aneurysms

Design outcomes

Primary

Measure	Time frame
1. The number of patients surviving aneurysm repair that agree to enroll in an RCT of rehabilitation vs standard therapy, to establish the proportion of those approached who agree to consent to entry to the CR programme 2. The level of compliance with cardiac rehabilitation (CR) therapy and attendance of the scheduled sessions	—

Secondary

Measure	Time frame
1. Time to death 2. Time to first cardiovascular event after aneurysm repair. This is a composite endpoint including non-fatal myocardial infarction, stroke, revascularization and nontraumatic amputation. The revascularization endpoint includes strictly defined procedures (coronary artery bypass graft surgery, percutaneous coronary interventions and percutaneous coronary interventions) and peripheral vascular procedures (embolectomy, bypass and angioplasty). In the absence of relevant COMET outcomes, this outcome measure mirrors the composite cardiovascular endpoint measured for previous randomised RCTs of cardiovascular risk reduction. Statistically adjusted analysis of the total number of events during follow-up will eventually minimise the risk that reporting only a 'composite cardiovascular disease event' endpoint may mask a treatment effect or ignore competing risk; for example, the intervention reducing the risk of one event but increase the risk of another. 3. Intermediate phenotypic markers of cardiovascular risk measured at enrolment, 12 weeks after entry to CR and 6 months after entry to CR: serum lipids (total cholesterol, HDL and LDL), systolic and diastolic blood pressure, HbA1C, BNP, Troponin, hsCRP, Fibrinogen, Homocysteine, urate, eGFR, serum insulin levels, and echocardiographic measure of cardiac function. We will also be testing for urinary microalbuminuria at enrolment, 12 weeks and 6 months. 4. Indicators of patient behavior and lifestyle/biometrics: waist:hip ratio and waist circumference, BMI, ankle-brachial pressure index (ABPI) and toe pressures. Smoking cessation outcomes will include: salivary cotinine, expiratory carbon monoxide, 'prolonged abstinence', and attendance at NHS stop-smoking services. 5. Quality of Life: EQ5D5L questionnaires will be administered at enrolment, 12 weeks after entry to CR and 6 months after entry to CR. 6. Cost-Effectiveness: Mean c	—

Measure

Time frame

1. Time to death 2. Time to first cardiovascular event after aneurysm repair. This is a composite endpoint including non-fatal myocardial infarction, stroke, revascularization and nontraumatic amputation. The revascularization endpoint includes strictly defined procedures (coronary artery bypass graft surgery, percutaneous coronary interventions and percutaneous coronary interventions) and peripheral vascular procedures (embolectomy, bypass and angioplasty). In the absence of relevant COMET outcomes, this outcome measure mirrors the composite cardiovascular endpoint measured for previous randomised RCTs of cardiovascular risk reduction. Statistically adjusted analysis of the total number of events during follow-up will eventually minimise the risk that reporting only a 'composite cardiovascular disease event' endpoint may mask a treatment effect or ignore competing risk; for example, the intervention reducing the risk of one event but increase the risk of another. 3. Intermediate phenotypic markers of cardiovascular risk measured at enrolment, 12 weeks after entry to CR and 6 months after entry to CR: serum lipids (total cholesterol, HDL and LDL), systolic and diastolic blood pressure, HbA1C, BNP, Troponin, hsCRP, Fibrinogen, Homocysteine, urate, eGFR, serum insulin levels, and echocardiographic measure of cardiac function. We will also be testing for urinary microalbuminuria at enrolment, 12 weeks and 6 months. 4. Indicators of patient behavior and lifestyle/biometrics: waist:hip ratio and waist circumference, BMI, ankle-brachial pressure index (ABPI) and toe pressures. Smoking cessation outcomes will include: salivary cotinine, expiratory carbon monoxide, 'prolonged abstinence', and attendance at NHS stop-smoking services. 5. Quality of Life: EQ5D5L questionnaires will be administered at enrolment, 12 weeks after entry to CR and 6 months after entry to CR. 6. Cost-Effectiveness: Mean c

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026