- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06250790
Selective Coronary Revascularization in Peripheral Artery Disease Patients (SCOREPAD Trial)
February 15, 2024 updated by: Pauls Stradins Clinical University Hospital
Selective Coronary Revascularization in Peripheral Artery Disease Patients After Lower-extremity Revascularization (SCOREPAD Trial)
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
This study targets a population of 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 computed tomography angiography (CTA), and no coronary revascularization (PCI or CABG) who have undergone successful lower extremity revascularization with planned post-operative best medical therapy.
Within 14 days following lower-extremity revascularization, patients will be randomly assigned to BMT alone or BMT plus coronary CT angiography (which must be completed within 14 days of randomization) and Fractional Flow Reserve Derived from CT (FFRct) analysis to determine the functional significance of coronary lesions identified on the CT scan.
Results of the CT scan and FFRCT analysis in patients randomized to the CT-FFRct group, will be provided to treating physicians to help guide patient management with Heart Team consideration for coronary angiography and revascularization as appropriate for each patient.
Coronary revascularisation (PCI or CABG), if indicated, is strongly recommended within 3 months from the randomisation.
Clinical follow up (based on date of randomization) is planned 6 months, one and 2 years.
Additional long-term follow up out to 5-years is planned for participating centers.
An independent academic clinical events committee will adjudicate all endpoints in a blinded manner.
The definition of outcome events will be in accordance with Academic Research Consortium-2 consensus document.
Study Type
Observational
Enrollment (Estimated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dainis Krievins, MD, PhD
- Phone Number: +371 29450000
- Email: dainis.krievins@gmail.com
Study Locations
-
-
-
Riga, Latvia
- Recruiting
- Pauls Stradins Clinical University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Adverse Cardiac Events
Time Frame: 2 years
|
A composite of cardiac death, myocardial infarction (MI) or urgent coronary revascularization
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Adverse Cardiac Events and survival
Time Frame: 2 years
|
Cardiac death, cardiovascular death, myocardial infarction (MI), urgent coronary revascularisation, all-cause death
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dainis Krievins, MD, PhD, Institute of Science, Pauls Stradins Clinical University Hospital
- Principal Investigator: Andrejs Erglis, MD, PhD, Pauls Stradins Clinical University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2024
Primary Completion (Estimated)
February 15, 2026
Study Completion (Estimated)
February 15, 2029
Study Registration Dates
First Submitted
February 1, 2024
First Submitted That Met QC Criteria
February 1, 2024
First Posted (Actual)
February 9, 2024
Study Record Updates
Last Update Posted (Actual)
February 16, 2024
Last Update Submitted That Met QC Criteria
February 15, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TBA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
San Luigi Gonzaga HospitalRecruitingCoronary Disease | STEMI | Coronary Artery Ectasia | Right Coronary Artery Occlusion | Right Coronary Artery StenosisSpain, Italy
Clinical Trials on Coronary CT angiography and FFRct analysis
-
HeartFlow, Inc.Case Western Reserve UniversityCompletedCoronary Artery DiseaseDenmark
-
St. Olavs HospitalNorwegian University of Science and Technology; Helse Nord-Trøndelag HF; Alesund... and other collaboratorsRecruitingNon-ST Elevated Myocardial InfarctionNorway
-
Assiut UniversityCompleted
-
University Hospital of PatrasCompletedCoronary Artery Bypass SurgeryGreece
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Recruiting
-
Shanghai Zhongshan HospitalActive, not recruiting
-
Seoul National University HospitalOdense University Hospital; University of British Columbia; Aarhus University... and other collaboratorsActive, not recruitingAcute Myocardial Infarction | Unstable AnginaKorea, Republic of
-
Johns Hopkins UniversityCanon Medical Systems, USARecruitingCoronary Artery DiseaseUnited States
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingPulmonary Arterial HypertensionItaly
-
University Medical Centre LjubljanaCompletedHeart Transplant Failure | VasculopathySlovenia