NCT06250790 Selective Coronary Revascularization in Peripheral Artery Disease Patients (SCOREPAD Trial)
| NCT ID | NCT06250790 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pauls Stradins Clinical University Hospital |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-02-15 |
| Primary Completion | 2026-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2024-02-15 with a primary completion date of 2026-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this study is to determine whether among symptomatic Peripheral Arterial Disease (PAD) patients with no known Coronary Artery Disease (CAD) who had undergone lower-extremity revascularization, a strategy of best medical therapy (BMT) plus selective coronary revascularization based on FFRct assessment of lesion-specific coronary ischemia can reduce adverse cardiac events and improve survival compared to BMT alone. Lesion-specific coronary ischemia is defined as FFRCT ≤0.80 distal to stenosis in a major (≥2 mm) coronary artery with severe ischemia defined as FFRCT ≤0.75.
Eligibility Criteria
Inclusion Criteria: 1. Inform consent obtained before any study-related activities; 2. Age above or equal to 50 years with symptomatic lower extremity PAD (severe claudication or chronic limb-threatening ischemia, Rutherford 3,4,5) which has been successfully revascularized by open surgical or endovascular procedure within the past 14 days; 3. Willing and able to undergo coronary CTA scan within 14 days of randomization and agrees to submission of CTA data set for HeartFlow FFRct analysis with results made available to treating physician. Exclusion Criteria: 1. Known CAD, history of MI, prior coronary revascularization (PCI or CABG); 2. Patient underwent coronary angiography or coronary CTA before the randomization; 3. Known history of 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; 4. History of severe asthma, severe or bronchodilator-dependent Chronic obstructive pulmonary disease (COPD); 5. Severe congestive heart failure (NYHA III or IV); 6. Severe arrhythmia, prior pacemaker or internal defibrillator lead implantation; 7. Impaired chronic renal function (EPI-Glomerular Filtration Rate (GFR)\<30ml/min); 8. Subjects with known anaphylactic allergy to iodinated contrast; 9. Pregnancy or unknown pregnancy status in subject of childbearing potential; 10. Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, or acute pulmonary edema; 11. Any active, serious, life-threatening disease with a life expectancy of less than 2 years; 12. Any active infection; 13. Inability to comply with study procedures; 14. Contraindication for guideline-guided longterm antiplatelet/anticoagulation regime after PCI/CABG; 15. Participation in any interventional clinical study within 30 days prior to screening.
Contact & Investigator
Dainis Krievins, MD, PhD
PRINCIPAL INVESTIGATOR
Institute of Science, Pauls Stradins Clinical University Hospital
Frequently Asked Questions
Who can join the NCT06250790 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06250790 currently recruiting?
Yes, NCT06250790 is actively recruiting participants. Contact the research team at dainis.krievins@gmail.com for enrollment information.
Where is the NCT06250790 trial being conducted?
This trial is being conducted at Riga, Latvia.
Who is sponsoring the NCT06250790 clinical trial?
NCT06250790 is sponsored by Pauls Stradins Clinical University Hospital. The principal investigator is Dainis Krievins, MD, PhD at Institute of Science, Pauls Stradins Clinical University Hospital. The trial plans to enroll 600 participants.