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| Name | Class |
|---|---|
| Poznan University of Medical Sciences | OTHER |
| Military Institute od Medicine National Research Institute | OTHER |
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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.
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
** MALE = Untreated restenosis or deterioration in patency of a previously revascularized vessel , Reintervention in the revascularized segment due to impaired patency, Amputation (either above or below the knee) of the revascularized limb.
Demographic and clinical data will be obtained from the medical records of patients hospitalized in three vascular surgery departments (Wrocław, Poznań, Warsaw), while information regarding MACE , MALE, and the use of SGLT2-i will be collected via telephone interviews with the patients (or their family members, if the patient is deceased).
The number of MACE and MALE incidents during the year following the procedure will be compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with SGLT2 inhibitors (flozins) | Drug | Patients received SGLT2 inhibitors (empagliflozin, dapagliflozin, canagliflozin) as part of their routine clinical care during the 12-month follow-up period after elective or urgent lower limb revascularization procedures. The study does not assign treatment; medication use occurred independently of the study protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)-Number of Participants Experiencing MACEor MALE | 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 | 12 months from the vascular intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Non-fatal Myocardial Infarction (MI) | Non-fatal myocardial infarction (MI), Unit of Measure: Number of participants Non-fatal stroke involving the central nervous system (CNS) Cardiovascular death Untreated loss or deterioration of patency in a previously revascularized vessel Repeat intervention in a revascularized segment due to impaired patency Amputation (above or below the knee) of the revascularized limb |
| Measure | Description | Time Frame |
|---|---|---|
| Additional secondary endpoint- Surgical site infection (SSI) | Surgical site infection occurring after the index vascular intervention. Unit of Measure: Number of participants | 12 months from vascular intervention |
| Additional secondary endpoint- Significant bleeding |
Inclusion Criteria:
Exclusion Criteria:
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The analyzed cases will involve patients from three major vascular clinics located in Wrocław, Poznań, and Warsaw.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edyta Sutkowska, M.D., Ph.D. | Contact | 48503077016 | edyta.sutkowska@umw.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Edyta Sutkowska, Ph.D | Wroclaw Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wroclaw Medical University | Recruiting | Wroclaw | Lower Silesian Voivodeship | Poland |
only IPD used in the results publication
Individual participant data (de-identified) and supporting documents will be available upon reasonable request from qualified researchers, starting 6 months after publication of the primary results and for a period of 5 years.
Anonymized individual participant data (IPD) may be shared upon reasonable request. Access will be considered for qualified researchers with a valid scientific proposal. Requests will be reviewed by the study team, and a data sharing agreement may be required.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2025 | Aug 27, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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|
| 12 months from the vascular intervention |
| Non-fatal Stroke Involving the Central Nervous System (CNS) | Non-fatal Stroke Involving the Central Nervous System (CNS), Unit of Measure: Number of participants | 12 months from the vascular intervention |
| Cardiovascular Death | Cardiovascular Death, Unit of Measure: Number of participants | 12 months from the vascular intervention |
| Loss or Deterioration of Patency in a Previously Revascularized Vessel | Loss or Deterioration of Patency in a Previously Revascularized Vessel, Unit of Measure: Number of participants | 12 months from the vascular intervention |
| Repeat intervention in a revascularized segment due to impaired patency | Repeat intervention in a revascularized segment due to impaired patency; Unit of Measure: Number of participants and number of limbs | 12 months from the vascular intervention |
| Amputation of the revascularized limb | Amputation (above or below the knee) of the revascularized limb; Unit of Measure: Number of participants and number of limbs | 12 months from the vascular intervention |
Clinically significant bleeding events as assessed by treating physician (according to established clinical criteria). Unit of Measure: Number of participants |
| 12 months from vascular intervention |
| Additional secondary endpoint- Kidney injury | Acute kidney injury occurring after vascular intervention, defined according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Unit of Measure: Number of participants | 12 months from vascular intervention |
| Additional secondary endpoint- Reintervention in the Same Vascular Segment | Readmission and repeat procedure in the same vascular segment due to impaired patency. Unit of Measure: Number of participants and number of limbs | 12 months from vascular intervention |
| Additional secondary endpoint- Foot Necrosis | Development of necrosis in the treated limb within the study period. Unit of Measure: Number of participants and number of limbs | 12 months from vascular intervention |
| Additional secondary endpoint- Minor Amputation | Minor amputation defined as amputation within the foot (below the ankle). Unit of Measure: Number of participants and number of limbs | 12 months from vascular intervention |
| Additional secondary endpoint- Heart Failure Hospitalization | Hospital admission with a primary diagnosis of heart failure. Unit of Measure: Number of participants | 12 months from vascular intervention |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D045505 | Physiological Effects of Drugs |