Leg Ischaemia Management Collaboration (LIMb)
Single-centre prospective cohort study of patients presenting with severe limb ischaemia (SLI). The primary outcome measure will be 12 month major amputation rate. A historical cohort of patients identified retrospectively will be the comparitor group used to assess the impact of a newly-established rapid-access limb salvage clinic.
Primary aim:
- Determine the proportion of patients with SLI undergoing major lower limb amputation within 12 months of presentation.
Secondary aims:
- Assess clinically important short-, medium- and long-term outcomes in those undergoing and not undergoing amputation
- Prevalence and degree of frailty and cognitive impairment
- Pevalence and degree of cardiac disease (detected by stress MRI)
- Establish a biobank for future biomarker analysis
- Investigate the role of frailty and cognitive assessments, cardiac MRI and biomarkers in risk-stratification of patients with SLI
調査の概要
詳細な説明
Severe limb ischaemia (SLI) is the end-stage of peripheral arterial occlusive disease (PAOD) whereby the viability of the limb is threatened due to the degree of arterial disease and subsequent ischaemia in the peripheral tissues. It is defined as ischaemic rest pain (or night pain) and/or ulceration or gangrene in the affected limb(s) for a minimum of two weeks attributed to confirmed PAOD. Treatment includes open surgical and endovascular revascularisation, with or without surgical debridement of affected tissues, amputation of toes and drainage of sepsis. In some patients revascularisation is not possible or fails resulting in the person requiring a major lower limb amputation.
Over 4000 major lower limb amputations per year were undertaken in England alone between 2003 and 2013 and a diabetes-related major lower limb amputation is performed every 30 seconds world-wide. As many as 25% of people with SLI will undergo a major lower limb amputation in the first year after presentation. Amputation negatively affects quality of life due to its negative impact on mobility, independence and ability to carry out activities of daily living.
This single-centre prospective cohort study will investigate the amputation rate at one year in patients presenting with SLI and compare this to a retrospectively identified historical cohort. This study will also investigate the prevelance and degree of frailty, cognitive impairment, and cardiac disease (detected by cardiac magnetic resonance imaging (MRI)), as well as establish a biobank for future biomarker analyses. The role of frailty and cognitive assessments, cardiac MRI and biomarker analysis in risk-stratifying patients with SLI will also be investigated.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Rob D Sayers, MD
- 電話番号:+44 (0)116 252 3141
- メール:rs152@le.ac.uk
研究連絡先のバックアップ
- 名前:Tanya J Payne, BSc
- 電話番号:+44 (0)116 258 3867
- メール:tjp28@le.ac.uk
研究場所
-
-
Leicestershire
-
Leicester、Leicestershire、イギリス、LE3 9QP
- 募集
- Glenfield Hospital Leicester
-
副調査官:
- Gerry P McCann, MD
-
コンタクト:
- Tanya J Payne
- 電話番号:+44 (0)116 358 3867
- メール:tjp28@le.ac.uk
-
主任研究者:
- Rob D Sayers, MD
-
副調査官:
- Matt J Bown, MD
-
副調査官:
- Thompson G Robinson, MD
-
副調査官:
- Victoria J Haunton, MD
-
副調査官:
- Sally J Singh, PhD
-
主任研究者:
- Robert SM Davies, MD
-
副調査官:
- Tanya J Payne, BSc
-
副調査官:
- Laura J Gray, PhD
-
副調査官:
- Harjeet S Rayt, MD
-
副調査官:
- Gregory S McMahon, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
PRIMARY COHORT
Inclusion Criteria:
- All patients presenting to the Leicester Vascular Institute with SLI
Exclusion Criteria:
- SLI not caused by PAOD
- Patients undergoing intervention during their index presentation prior to recruitment
- Patients lacking capacity to consent with no accompanying next of kin, relative, partner or friend who can act as a personal consulted
- Patients who cannot read, write or understand English
- Any significant disease or disorder which may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study
FRAILTY & COGNITIVE ADDITIONAL ASSESSMENTS
Inclusion criteria:
- Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention for SLI
- Patients aged ≥65 years
Exclusion criteria:
- Nil additional
CARDIAC MRI ADDITIONAL ASSESSMENTS
Inclusion criteria:
- Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention
Exclusion criteria:
- Absolute contraindications to cardiac MRI (Pregnancy, Non-MR safe permanent pacemaker, implanted cardiac defibrillator, intra-auricular implant or intra-cranial clips, severe claustrophobia, unstable angina)
- Contraindication to gadolinium contrast agent (Known adverse reaction, chronic renal failure (eGFR <30mL/min/1.73m^2))
- Patients lacking capacity to consent for cardiac MRI
BIOMARKERS ADDITIONAL ASSESSMENTS
- Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention
Exclusion criteria:
- Nil additional
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
---|
Primary cohort
Any patient presenting to the Leicester Vascular Institute with SLI during the 2 year recruitment period (minimum 420 patients).
|
Frailty & cognitive additional assessments
Any patient recruited to the primary cohort aged ≥65 years and undergoing an intervention for SLI (minimum 150 patients, target 210 patients).
|
Cardiac MRI additional assessments
Any patient recruited to the primary cohort, with capacity to consent and undergoing an intervention for SLI (minimum 100 patients).
|
Biomarkers additional assessments
Any patient recruited to the primary cohort and undergoing an intervention for SLI (no target recruitment set).
|
Historical cohort
Retrospectively identified cohort of patients presenting to the study site with SLI between 2013 -15 (target 420).
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
12 month amputation rate
時間枠:12 months post recruitment
|
Proportion of patients undergoing major lower limb amputation
|
12 months post recruitment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Amputation free survival
時間枠:≥12 months post recruitment
|
Composite outcome measure of death or amputation
|
≥12 months post recruitment
|
All-cause mortality
時間枠:≥12 months
|
Death from any cause
|
≥12 months
|
Quality of life
時間枠:12 and 24 months post recruitment
|
Quality of life as measured by the Vascular Quality of Life questionnaire (VascuQoL)
|
12 and 24 months post recruitment
|
Disability
時間枠:12 and 24 months post recruitment
|
Level of disability as measured by the Barthel Index - Score 0-20; higher score = greater degree of functional independence/lower level of disability |
12 and 24 months post recruitment
|
Clinical Frailty Scale
時間枠:Baseline, 12 and 24 months
|
Prevalence and degree of frailty as measured by the Clinical Frailty Scale (CFS)
|
Baseline, 12 and 24 months
|
Anxiety & Depression
時間枠:Baseline, 12 and 24 months
|
Prevalence and degree of anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)
|
Baseline, 12 and 24 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Cognitive impairment (Frailty & Cognitive additional assessments only)
時間枠:Baseline, 3 and 12 months
|
Prevalence of cognitive impairment as detected by the Montreal Cognitive Assessment (MoCA)
|
Baseline, 3 and 12 months
|
Post-operative delirium (Frailty & Cognitive additional assessments only)
時間枠:24 and 72 hours post intervention
|
Incidence of post-operative delirium as detected by the Single Question in Delirium (SQiD) +/- 4 A's Test for delirium (4AT)
|
24 and 72 hours post intervention
|
Prevalence of coronary artery disease (Cardiac MR additional assessments only)
時間枠:Baseline
|
Prevalence of coronary artery disease as detected by stress cardiac MRI
|
Baseline
|
Incidence of peri-operative myocardial infarction (Cardiac MR additional assessments only)
時間枠:2-4 months post intervention
|
Incidence of peri-operative myocardial infarction as detected by cardiac MRI
|
2-4 months post intervention
|
Edmonton Frail Scale (Frailty & Cognitive additional assessments only)
時間枠:Baseline, 3 and 12 months
|
Prevalence and degree of frailty as measured by the Edmonton Frail Scale (EFS)
|
Baseline, 3 and 12 months
|
協力者と研究者
スポンサー
協力者
捜査官
- スタディチェア:Rob D Sayers, MD、University of Leicester
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 0686
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
冠動脈疾患の臨床試験
-
Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ