Ocena powikłań Naczyniowych u pacjentów Poddanych Rewaskularyzacji Obwodowej: wpływ inhibitorów SGLT-2 The Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)-Number of Participants Experiencing MACEor MALE
研究概览
简要总结
The study is observational and involves patients (pts) with peripheral arterial occlusive disease (PAD) who have undergone lower limb revascularization procedures. Patients who are at least one year post-procedure will be contacted by phone and asked whether any cardiovascular complications occurred during that period, specifically major adverse cardiovascular events (MACE) or major adverse limb events (MALE), and whether they had been taking sodium-glucose co-transporter 2 inhibitors (SGLT2-i, "flozins") during the year following the procedure. The results from the group of pts who, for any reason, received SGLT2-i treatment after the vascular procedure (including those who had initiated treatment before surgery) will be compared to the results from the group of patients who did not receive such treatment, with regard to the occurrence of the aforementioned complications.
详细描述
Project Objective: To assess the impact of SGLT2 inhibitors (SGLT2-i) on vascular complications in patients undergoing peripheral revascularization.
Specific Objective: To evaluate the incidence of 3-point MACE* (Major Adverse Cardiac Events) and MALE** (Major Adverse Limb Events) following vascular surgical procedures (both open and minimally invasive), performed in patients treated with SGLT2- i vs controls ( non-treated pts).
Observation Period: One year - assessment at 30 days, 3 months, and 1 year post-procedure.
Definitions for:
* MACE = Non-fatal myocardial infarction (MI),Non-fatal stroke involving the central nervous system (CNS), Cardiovascular death
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peripheral vascular procedure ( Conventional surgical procedure or minimally invasive procedure) due to acute or chronic ischemia
- •Use of SGLT2 inhibitors (applies only to the group exposed to flozins) for at least 3 months prior to the vascular procedure (the indication for initiating the drug is irrelevant: chronic kidney disease [CKD] / cardiac reasons / diabetes), or immediately after the vascular procedure
- •Ability to determine the patient's outcomes within a minimum of 30 days up to 1 year following the vascular procedure
排除标准
- •Vascular injury as the reason for the procedure
- •Amputation due to causes other than ischemia (e.g., cancer, neuropathy, trauma without coexisting ischemia)
- •Planned revascularization procedure other than for the lower limbs at the time of hospital discharge (e.g., coronary or carotid arteries)
- •Planned ischemia-related amputation or reoperation of the operated limb at the time of hospital discharge
- •Planned other major surgical procedure with high cardiovascular risk at the time of hospital discharge
研究组 & 干预措施
Patients after vascular surgery treated with flozins
Patients aged ≥18 years who have undergone vascular surgery (either open or minimally invasive procedures) and, for any reason, were treated with SGLT2 inhibitors ("flozins") during the one-year follow-up period after the procedure.
干预措施: Treatment with SGLT2 inhibitors (flozins) (Drug)
Patients after vascular surgery with no exposure to flozins (controls)
Patients aged ≥18 years who have undergone vascular surgery (either open or minimally invasive procedures) and were not exposed to SGLT2 inhibitors ("flozins") during the one-year follow-up period after the procedure.
结局指标
主要结局
MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)-Number of Participants Experiencing MACEor MALE
时间窗: 12 months from the vascular intervention
MACE is defined as a composite of : Non-fatal myocardial infarction (MI); Non-fatal stroke involving the central nervous system (CNS); or Cardiovascular death MALE is defined as a composite of : Untreated loss or deterioration of patency in a previously revascularized vessel; Repeat intervention in a revascularized segment due to impaired patency, or Amputation (above or below the knee) of the revascularized limb Unit of Measure: Number of participants with at least one event
次要结局
- Non-fatal Myocardial Infarction (MI)(12 months from the vascular intervention)
- Non-fatal Stroke Involving the Central Nervous System (CNS)(12 months from the vascular intervention)
- Cardiovascular Death(12 months from the vascular intervention)
- Loss or Deterioration of Patency in a Previously Revascularized Vessel(12 months from the vascular intervention)
- Repeat intervention in a revascularized segment due to impaired patency(12 months from the vascular intervention)
- Amputation of the revascularized limb(12 months from the vascular intervention)
研究者
Edyta Sutkowska
M.D., Ph.D.
Wroclaw Medical University