Peripheral Arterial DiseaseNCT06250790
Selective Coronary Revascularization in Peripheral Artery Disease Patients (SCOREPAD Trial)
An observational study of Peripheral Arterial Disease and Coronary Artery Disease, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Coronary Artery Disease
- What is being tested?
- Coronary CT angiography and FFRct analysis
- How many people
- 600 participants
- Where
- 1 siteLatvia
- Study dates
- 15 Feb 2024to 15 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Latvia1 site, 1 recruiting
- Recruiting
Pauls Stradins Clinical University hospital
Riga
About this study
Official title: 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.
Read the 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.
- Being tested
- Coronary CT angiography and FFRct analysis
- Medical subject headings
- Peripheral Arterial Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT angiography and FFRct analysisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Coronary CT angiography and FFRct analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events
A composite of cardiac death, myocardial infarction (MI) or urgent coronary revascularization
Measured: 2 years
Secondary outcomes (1)
Major Adverse Cardiac Events and survival
Cardiac death, cardiovascular death, myocardial infarction (MI), urgent coronary revascularisation, all-cause death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start15 Feb 2024
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pauls Stradins Clinical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dainis Krievins, MD, PhD, Principal investigator, Institute of Science, Pauls Stradins Clinical University HospitalAndrejs Erglis, MD, PhD, Principal investigator, Pauls Stradins Clinical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250790
- Sponsor's protocol ID
- TBA
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Coronary Revascularization in Peripheral Artery Disease Patients After Lower-extremity Revascularization (SCOREPAD Trial)
- ClinicalTrials.gov ID
- NCT06250790
- Acronym / sponsor ID
- TBA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Pauls Stradins Clinical University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Feb 2029 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: Coronary CT angiography and FFRct analysisPatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary CT angiography and FFRct analysisA 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. | Diagnostic test | Assigned to Best Medical Therapy (BMT) + coronary CT angiography + CT-FFRct analysis |
Primary outcome
Major Adverse Cardiac Events
Time frame: 2 years
A composite of cardiac death, myocardial infarction (MI) or urgent coronary revascularization
1 secondary outcome
Major Adverse Cardiac Events and survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dainis Krievins, MD, PhD principal investigator
Institute of Science, Pauls Stradins Clinical University Hospital
Andrejs Erglis, MD, PhD principal investigator
Pauls Stradins Clinical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Coronary Artery Disease, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dainis Krievins, MD, PhD (+371 29450000, dainis.krievins@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.