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Diagnostic Test

Investigational Treatment Strategy for Coronary Artery Disease (CAD in sPAD Trial)

Q: Who is eligible to partake in this clinical trial?

To participate in this research, individuals need to have been diagnosed with coronary artery disease and be between 50 and 85 years old. The study aims to recruit approximately 450 eligible volunteers.

Q: Is the current clinical trial open for patient enrollment at this time?

Per clinicaltrials.gov, this investigation is presently not in need of participants. Originally shared on August 1st, 2024, the most recent update was made on April 23rd, 2024. However, it should be noted that out of the total ongoing studies listed on the platform at present, there are a notable 776 actively seeking enrollees.

Q: Is the age group of individuals aged 70 and above considered eligible for participation in this clinical trial?

Patients between 50 and 85 years old are eligible for participation in this trial. Among the studies listed, there are 33 trials catering to individuals below 18 years of age and 762 focused on those over 65.

Q: In how many distinct clinics is this experimental investigation currently being conducted?

This research is being conducted at the North <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>/South <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a> Veterans Health System in Gainesville, FL; Louis Stokes VA Medical Center in Cleveland, OH; and VA Pittsburgh Healthcare System University Drive Division in Pittsburgh, PA. Additionally, there are seven more locations involved in this study.

N/A

Waitlist Available

Led By Clay Quint, MD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female 50 to 85

Severe intermittent claudication with ABI < 0.6 or monophasic waveform if non-compressible and TBI < 0.6

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

CAD in sPAD Trial Summary

This trial aims to improve the outcomes of patients with severe peripheral artery disease in the Veteran population by developing a management strategy following lower leg revascularization procedures. The long-term mortality rate for these patients is

Who is the study for?

This trial is for veterans with severe peripheral artery disease (PAD) who have undergone surgery or endovascular intervention to restore blood flow in their legs. Participants should be at high risk of cardiovascular issues post-revascularization.Check my eligibility

What is being tested?

The study is testing the use of coronary CT angiography combined with FFR-CT, a non-invasive imaging technique, to develop a management strategy aimed at improving cardiovascular outcomes in patients with severe PAD after leg revascularization.See study design

What are the potential side effects?

Coronary CT angiography may cause discomfort due to contrast dye, allergic reactions, and exposure to radiation. The side effects are generally mild but can vary based on individual health conditions.

CAD in sPAD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 85 years old.

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I have severe leg pain when walking and very poor blood flow in my legs.

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I have minor tissue loss in my leg and very poor blood flow.

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I have severe leg pain even when resting due to poor blood flow.

CAD in sPAD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Major adverse cardiovascular events (MACE)

Secondary outcome measures

All-cause mortality

Amputation-free survival

Cardiovascular-related death

+1 more

CAD in sPAD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Investigational Treatment StrategyExperimental Treatment1 Intervention

This arm will have a coronary CTA with FFR-CT with selective coronary artery revascularization plus optimal medical therapy after lower extremity revascularization

Group II: StandardActive Control1 Intervention

This arm will have optimal medical therapy after lower extremity revascularization

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,612 Previous Clinical Trials

3,305,293 Total Patients Enrolled

8 Trials studying Coronary Artery Disease

9,497 Patients Enrolled for Coronary Artery Disease

Clay Quint, MD PhDPrincipal InvestigatorRocky Mountain Regional VA Medical Center, Aurora, CO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to partake in this clinical trial?

"To participate in this research, individuals need to have been diagnosed with coronary artery disease and be between 50 and 85 years old. The study aims to recruit approximately 450 eligible volunteers."

Answered by AI

Is the current clinical trial open for patient enrollment at this time?

"Per clinicaltrials.gov, this investigation is presently not in need of participants. Originally shared on August 1st, 2024, the most recent update was made on April 23rd, 2024. However, it should be noted that out of the total ongoing studies listed on the platform at present, there are a notable 776 actively seeking enrollees."

Answered by AI

Is the age group of individuals aged 70 and above considered eligible for participation in this clinical trial?

"Patients between 50 and 85 years old are eligible for participation in this trial. Among the studies listed, there are 33 trials catering to individuals below 18 years of age and 762 focused on those over 65."

Answered by AI

In how many distinct clinics is this experimental investigation currently being conducted?

"This research is being conducted at the North Florida/South Georgia Veterans Health System in Gainesville, FL; Louis Stokes VA Medical Center in Cleveland, OH; and VA Pittsburgh Healthcare System University Drive Division in Pittsburgh, PA. Additionally, there are seven more locations involved in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization

2024. "Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06387355.

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