Selective Coronary Revascularization in Peripheral Artery Disease Patients (SCOREPAD Trial)

NCT06250790 | Recruiting

• 1 other identifier: TBA
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac Events

  A composite of cardiac death, myocardial infarction (MI) or urgent coronary revascularization

  2 years

Secondary Outcomes (1)

• Major Adverse Cardiac Events and survival

  2 years

Study Arms (2)

Assigned to Best Medical Therapy (BMT) alone

Patients who have undergone successful lower extremity revascularization and are assigned to BMT alone within 14 days following revascularization.

Assigned to Best Medical Therapy (BMT) + coronary CT angiography + CT-FFRct analysis

Patients who have undergone successful lower extremity revascularization and are assigned to BMT plus coronary CT angiography (which must be completed within 14 days of randomization) and FFRct analysis to determine the functional significance of coronary lesions identified on the CT scan.

Diagnostic Test: Coronary CT angiography and FFRct analysis

Interventions

Coronary CT angiography and FFRct analysis DIAGNOSTIC_TEST

A new non-invasive cardiac diagnostic test, coronary CT-derived fractional flow reserve (FFRCT) provides a unified anatomic and functional assessment of coronary artery disease which can reliably identify ischemia-producing coronary lesions. FFRCT accurately reflects invasively measured FFR and can help guide patient management and coronary revascularization decisions.

Assigned to Best Medical Therapy (BMT) + coronary CT angiography + CT-FFRct analysis

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with symptomatic PAD (CLTI or severe claudication in 1:1 ratio) and no prior cardiac history, no myocardial infarction, no coronary angiography or coronary CTA, and no coronary revascularization (PCI or CABG) who have undergone successful lower extremity revascularization with planned post-operative best medical therapy.

You may qualify if:

• Inform consent obtained before any study-related activities;
• 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;
• 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.

You may not qualify if:

• Known CAD, history of MI, prior coronary revascularization (PCI or CABG);
• Patient underwent coronary angiography or coronary CTA before the randomization;
• Known history of 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome;
• History of severe asthma, severe or bronchodilator-dependent Chronic obstructive pulmonary disease (COPD);
• Severe congestive heart failure (NYHA III or IV);
• Severe arrhythmia, prior pacemaker or internal defibrillator lead implantation;
• Impaired chronic renal function (EPI-Glomerular Filtration Rate (GFR)\<30ml/min);
• Subjects with known anaphylactic allergy to iodinated contrast;
• Pregnancy or unknown pregnancy status in subject of childbearing potential;
• 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;
• Any active, serious, life-threatening disease with a life expectancy of less than 2 years;
• Any active infection;
• Inability to comply with study procedures;
• Contraindication for guideline-guided longterm antiplatelet/anticoagulation regime after PCI/CABG;
• Participation in any interventional clinical study within 30 days prior to screening.

Sponsors & Collaborators

• Pauls Stradins Clinical University Hospital: lead

Study Sites (1)

Pauls Stradins Clinical University hospital

Riga, Latvia

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Officials

• Dainis Krievins, MD, PhD

  Institute of Science, Pauls Stradins Clinical University Hospital

  PRINCIPAL INVESTIGATOR

• Andrejs Erglis, MD, PhD

  Pauls Stradins Clinical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dainis Krievins, MD, PhD

CONTACT

+371 29450000; dainis.krievins@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: February 15, 2024
• Primary Completion: February 15, 2026
• Study Completion (Estimated): February 15, 2029
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)