SGLT2 inhibitors and vascular complications after lower limb revascularization.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study of patients with peripheral arterial disease who underwent lower limb revascularization at three vascular surgery departments in Poland. Investigators will extract demographic and clinical data from hospital records and contact patients (or family members) by telephone at 30 days, 3 months, and 1 year to document major adverse cardiac events (3-point MACE), major adverse limb events (MALE), and use of SGLT2 inhibitors. Patients who used SGLT2 inhibitors for at least three months before the procedure or who started them immediately after the procedure will be compared to patients who did not receive these drugs. The primary analysis compares the incidence of predefined MACE and MALE events during the year following the index revascularization.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Wroclaw Medical University
  Wroclaw, Lower Silesian Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Edyta Sutkowska, M.D., Ph.D.
• Email: edyta.sutkowska@umw.edu.pl
• Phone: 48503077016

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.