Coronary Artery DiseasePhase 4VA CARDSNCT00326196
Coronary Artery Revascularization in Diabetes
A Phase 4 study testing Percutaneous coronary intervention (PCI) and Coronary artery bypass graft (CABG) in people with Coronary Artery Disease, run by US Department of Veterans Affairs at 26 sites in United States.
Trial summary
This is a randomized, multi-site, clinical trial comparing percutaneous coronary stenting (PCI) with drug eluding stents to coronary bypass for angiographically significant coronary artery disease in diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention (PCI) and Coronary artery bypass graft (CABG)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 26 sitesUnited States
- Study dates
- Jul 2006to Aug 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diabetes with severe coronary artery disease General Inclusion Criteria
- Age at least 18 years old
- Patients with either Type I or Type II diabetes with a documented HbA1c greater than site ULN (If not on diabetic medication must be confirmed by a blood glucose of >126 mg/dL fasting, or >200mg/dL non-fasting); OR on diabetic medication with a documented physician diagnosis of diabetes mellitus.
- No child bearing potential (if female)
- Patient competent to provide consent
Who cannot join
- General Exclusion Criteria
- Congenital heart disease
- Coronary bypass surgery within the preceding one year
- Need for concomitant cardiac surgery
- AHA Class III decompensated heart failure or AHA Class IV heart failure
- Undergoing PCI for hemodynamic instability related to acute STEMI
Show all 18Show fewer
- History of a hemorrhagic stroke
- Severe bleeding diathesis
- History of chronic pancreatitis
- A severe co-morbid condition that is expected to limit life to less than two years
- Embolic stroke in the past six months
- Significant GI bleed within the last one month
- Lack of adequate surgical conduit
- Sensitivity to clopidogrel (Plavix)
- Sensitivity to glycoprotein IIb/IIIa inhibitors
- Chronic systemic steroid use
- Participation in another trial with active intervention
- Patient unable to be adequately followed
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
VA Medical Center, Asheville
Asheville, North Carolina, 28805
VA Medical Center, Birmingham
Birmingham, Alabama, 35233
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, 02301
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, 29401-5799
VA Medical Center, Cleveland
Cleveland, Ohio, 44106
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220
VA Medical Center, Durham
Durham, North Carolina, 27705
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884
VA Medical Center, Memphis
Memphis, Tennessee, 38104
VA Medical Center, Miami
Miami, Florida, 33125
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, 53295-1000
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
New York Harbor HCS
New York, New York, 10010
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, 73104
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
VA South Texas Health Care System, San Antonio
San Antonio, Texas, 78229
VA San Diego Healthcare System, San Diego
San Diego, California, 92161
VA Medical Center, San Francisco
San Francisco, California, 94121
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108
VA Greater Los Angeles HCS, Sepulveda
Sepulveda, California, 91343
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, 85723
VA Medical Center, DC
Washington D.C., District of Columbia, 20422
About this study
Official title: CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)
This is a randomized, multi-site, clinical trial comparing percutaneous coronary stenting (PCI) with drug eluding stents to coronary bypass for angiographically significant coronary artery disease in diabetes. The hypothesis being tested is that a strategy of surgical revascularization is superior to percutaneous intervention in preventing death or myocardial infarction in diabetics with severe ischemic heart disease.
Read the detailed description
Diabetic patients (HbA1c greater than 6.0% if treated or greater than 6.9% untreated) with severe ischemic heart disease and clinical indications for coronary revascularization will be screened and, if agreeable, entered into the study. Qualified patients unwilling to participate in the randomized trial will be approached for participation in a Registry that will collect computerized health data. The study consists of a 4-year accrual period. The median follow-up will be 3.7 years with a maximum of six years and a minimum of two years. Six sites will begin recruitment in the first year followed by nine additional sites for the remaining three years. The study is powered to detect a 40% relative difference between the groups in time to death or MI with a two-sided, type I error of 5% and a power of 90%.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG)
- Keywords
- CABG, Coronary Disease, Diabetes, PCI
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Device
percutaneous coronary stenting with drug eluding stents
Coronary artery bypass graft (CABG)Procedure or surgery
coronary bypass
| Study group | Role | What they receive |
|---|---|---|
| PCI | Active comparator | Percutaneous coronary intervention Receives: Device: Percutaneous coronary intervention (PCI); Procedure: Coronary artery bypass graft (CABG) |
| CABG | Active comparator | Coronary artery bypass graft (CABG) Receives: Procedure: Coronary artery bypass graft (CABG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hypothesis Being Tested is That a Strategy of Initial Surgical Revascularization is Superior to Percutaneous Intervention in Preventing Death or Myocardial Infarction in Diabetics With Severe Ischemic Heart Disease Assessed up to 4 Years.
Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.
Measured: Date of Death and non-fatal MI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startJul 2006
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Lack of participant enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Masoor Kamalesh, MD, Study chair, Richard Roudebush VA Medical Center, Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326196
- Sponsor's protocol ID
- 557
- Acronym
- VA CARDS
- Status last verified
- Apr 2014
- First submitted
- 12 May 2006
- Last updated
- 25 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kamalesh M, Sharp TG, Tang XC, Shunk K, Ward HB, Walsh J, King S 3rd, Colling C, Moritz T, Stroupe K, Reda D; VA CARDS Investigators. Percutaneous coronary intervention versus coronary bypass surgery in United States veterans with diabetes. J Am Coll Cardiol. 2013 Feb 26;61(8):808-16. doi: 10.1016/j.jacc.2012.11.044.
PubMed 23428214
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)
- ClinicalTrials.gov ID
- NCT00326196
- Acronym / sponsor ID
- VA CARDS / 557
- Conditions
- Coronary Artery Disease
- Keywords
- CABG, Coronary Disease, Diabetes, PCI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participant enrollment
- Enrolment
- 198 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2006
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 May 2006 (estimated)
- Results
- Posted 6 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, multi-site, clinical trial comparing percutaneous coronary stenting (PCI) with drug eluding stents to coronary bypass for angiographically significant coronary artery disease in diabetes. The hypothesis being tested is that a strategy of surgical revascularization is superior to percutaneous intervention in preventing death or myocardial infarction in diabetics with severe ischemic heart disease.
Detailed description
Diabetic patients (HbA1c greater than 6.0% if treated or greater than 6.9% untreated) with severe ischemic heart disease and clinical indications for coronary revascularization will be screened and, if agreeable, entered into the study. Qualified patients unwilling to participate in the randomized trial will be approached for participation in a Registry that will collect computerized health data. The study consists of a 4-year accrual period. The median follow-up will be 3.7 years with a maximum of six years and a minimum of two years. Six sites will begin recruitment in the first year followed by nine additional sites for the remaining three years. The study is powered to detect a 40% relative difference between the groups in time to death or MI with a two-sided, type I error of 5% and a power of 90%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI | Active comparator | Device: Percutaneous coronary intervention (PCI), Procedure: Coronary artery bypass graft (CABG)Percutaneous coronary intervention |
| CABG | Active comparator | Procedure: Coronary artery bypass graft (CABG)Coronary artery bypass graft (CABG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with diabetes with severe coronary artery disease General Inclusion Criteria
- Age at least 18 years old
- Patients with either Type I or Type II diabetes with a documented HbA1c greater than site ULN (If not on diabetic medication must be confirmed by a blood glucose of >126 mg/dL fasting, or >200mg/dL non-fasting); OR on diabetic medication with a documented physician diagnosis of diabetes mellitus.
- No child bearing potential (if female)
- Patient competent to provide consent
Key exclusion criteria (18 listed)
- General Exclusion Criteria
- Congenital heart disease
- Coronary bypass surgery within the preceding one year
- Need for concomitant cardiac surgery
- AHA Class III decompensated heart failure or AHA Class IV heart failure
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 |
|---|---|---|
| Percutaneous coronary intervention (PCI)percutaneous coronary stenting with drug eluding stents | Device | PCI |
| Coronary artery bypass graft (CABG)coronary bypass | Procedure or surgery | CABG, PCI |
Primary outcome
The Hypothesis Being Tested is That a Strategy of Initial Surgical Revascularization is Superior to Percutaneous Intervention in Preventing Death or Myocardial Infarction in Diabetics With Severe Ischemic Heart Disease Assessed up to 4 Years.
Time frame: Date of Death and non-fatal MI
Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23428214Kamalesh M, Sharp TG, Tang XC, Shunk K, Ward HB, Walsh J, King S 3rd, Colling C, Moritz T, Stroupe K, Reda D; VA CARDS Investigators. Percutaneous coronary intervention versus coronary bypass surgery in United States veterans with diabetes. J Am Coll Cardiol. 2013 Feb 26;61(8):808-16. doi: 10.1016/j.jacc.2012.11.044.
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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. This study is not recruiting at the moment.
Masoor Kamalesh, MD study chair
Richard Roudebush VA Medical Center, Indianapolis
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Percutaneous coronary intervention (PCI) and Coronary artery bypass graft (CABG) in people with Coronary Artery Disease, run by US Department of Veterans Affairs at 26 sites in United States.
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 5 inclusion and 18 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: stopped early, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hypothesis Being Tested is That a Strategy of Initial Surgical Revascularization is Superior to Percutaneous Intervention in Preventing Death or Myocardial Infarction in Diabetics With Severe Ischemic Heart Disease Assessed up to 4 Years. (time frame: Date of Death and non-fatal MI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00326196, which also lists 1 linked publication.
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 25 Apr 2014.