AnginaNCT01665833
Impact of Coronary Anatomy on Angina Relief in Patients Undergoing Coronary Revascularization
An observational study of Angina and Status Post PCI, run by North Texas Veterans Healthcare System.
Trial summary
We hypothesize that Coronary Artery Disease (CAD) severity assessed by SYNTAX score is an independent predictor of recurrent or persistent angina following coronary revascularization. The SYNTAX score is a score that suggests the severity of coronary artery disease detected by coronary angiography. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angina, Status Post PCI, Status Post CABG
- How many people
- 4,000,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We propose all patients between January 1, 2003 and December 31, 2011 who underwent an uncomplicated coronary revascularization with PCI and/or CABG for chronic stable angina within the VA. The data set that includes this information is the same as was used for study 09-018 (VA-CAP Study).
Who may be able to join
- Any VA patient who has had an PCI from January 1, 2003 and December 31, 2011 and in the database used in protocol 09-018 (VA-CAP Study).
- Any VA patient who has received or will receive a 1-year follow up.
Who cannot join
None listed.
About this study
Official title: A Retrospective Analysis Determining the Impact of Coronary Anatomy on Angina Relief in Patients Undergoing Coronary
We hypothesize that Coronary Artery Disease (CAD) severity assessed by SYNTAX score is an independent predictor of recurrent or persistent angina following coronary revascularization. The SYNTAX score is a score that suggests the severity of coronary artery disease detected by coronary angiography. Coronary revascularization is a procedure that occurs in two ways, a percutaneous coronary intervention (PCI) and a coronary artery bypass graft (CABG) and is done when there is narrowing and blockage or hardening of the arteries (atherosclerosis) surrounding the heart. Narrowing and blockages reduce blood flow to parts of the heart causing chest pain (known as angina) and sometimes myocardial infarction.
Read the detailed description
PCI and CABG are two well-established revascularization approaches to treatment of chronic angina caused by coronary atherosclerosis. Nevertheless, 35-42% of patients report recurring or persisting anginal symptoms after coronary revascularization. This can be attributed to many structural and functional causes, prominent amongst which is pre-revascularization angina severity, unrevascularized coronary territory, progression of native or bypass graft atherosclerosis, restenosis (re-narrowing of the vessels) and accompanying adjunctive pharmacotherapy.
The SYNTAX score is an angiographic tool for grading the complexity of coronary disease. It is the sum of points assigned to coronary lesions within one of the 16 segments of the coronary tree. The segments are given a 1,2, or 5 based on the disease presence as defined by the American Heart Association classification. The SYNTAX score has been used to help predict the outcomes of patients undergoing PCI with 3-vessel involvement (e.g. a triple bypass or 3-stent placement PCI). Those patients with the highest scores had the highest risk of a poor outcome with PCI revascularization compared to CABG. Despite these observations, the impact of CAD severity on post-revascularization angina, using the SYNTAX has never been systematically addressed in the current era.
- Conditions
- Angina, Status Post PCI, Status Post CABG
- Keywords
- Angina, SYNTAX, Coronary, PCI, CABG
- Medical subject headings
- Angina Pectoris
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard Rate
Primary and secondary endpoints
Measured: 1 year follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startJan 2003
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnginaStudies 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
- Time perspective
- Retrospective
- Enrolment
- 4,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Subhash Banerjee, North Texas Veterans Healthcare System
- Investigators
- Subhash Banerjee, MD, Principal investigator, Dallas VA Medical CenterEmmanouil Brilakis, MD,PhD, Principal investigator, Dallas VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665833
- Sponsor's protocol ID
- SYNTAX
- Status last verified
- Aug 2012
- First submitted
- 13 Aug 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
Publications
Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18.
PubMed 19228612
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis Determining the Impact of Coronary Anatomy on Angina Relief in Patients Undergoing Coronary
- ClinicalTrials.gov ID
- NCT01665833
- Acronym / sponsor ID
- SYNTAX
- Conditions
- Angina, Status Post PCI, Status Post CABG
- Keywords
- Angina, SYNTAX, Coronary, PCI, CABG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000,000 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- Jan 2003
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Aug 2012 (estimated)
- 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.
We hypothesize that Coronary Artery Disease (CAD) severity assessed by SYNTAX score is an independent predictor of recurrent or persistent angina following coronary revascularization. The SYNTAX score is a score that suggests the severity of coronary artery disease detected by coronary angiography. Coronary revascularization is a procedure that occurs in two ways, a percutaneous coronary intervention (PCI) and a coronary artery bypass graft (CABG) and is done when there is narrowing and blockage or hardening of the arteries (atherosclerosis) surrounding the heart. Narrowing and blockages reduce blood flow to parts of the heart causing chest pain (known as angina) and sometimes myocardial infarction.
Detailed description
PCI and CABG are two well-established revascularization approaches to treatment of chronic angina caused by coronary atherosclerosis. Nevertheless, 35-42% of patients report recurring or persisting anginal symptoms after coronary revascularization. This can be attributed to many structural and functional causes, prominent amongst which is pre-revascularization angina severity, unrevascularized coronary territory, progression of native or bypass graft atherosclerosis, restenosis (re-narrowing of the vessels) and accompanying adjunctive pharmacotherapy.
The SYNTAX score is an angiographic tool for grading the complexity of coronary disease. It is the sum of points assigned to coronary lesions within one of the 16 segments of the coronary tree. The segments are given a 1,2, or 5 based on the disease presence as defined by the American Heart Association classification. The SYNTAX score has been used to help predict the outcomes of patients undergoing PCI with 3-vessel involvement (e.g. a triple bypass or 3-stent placement PCI). Those patients with the highest scores had the highest risk of a poor outcome with PCI revascularization compared to CABG. Despite these observations, the impact of CAD severity on post-revascularization angina, using the SYNTAX has never been systematically addressed in the current era.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We propose all patients between January 1, 2003 and December 31, 2011 who underwent an uncomplicated coronary revascularization with PCI and/or CABG for chronic stable angina within the VA. The data set that includes this information is the same as was used for study 09-018 (VA-CAP Study).
Key inclusion criteria (2 listed)
- Any VA patient who has had an PCI from January 1, 2003 and December 31, 2011 and in the database used in protocol 09-018 (VA-CAP Study).
- Any VA patient who has received or will receive a 1-year follow up.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hazard Rate
Time frame: 1 year follow ups
Primary and secondary endpoints
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
- Results publication: PubMed 19228612Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18.
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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.
Subhash Banerjee, MD principal investigator
Dallas VA Medical Center
Emmanouil Brilakis, MD,PhD principal investigator
Dallas VA Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Angina and Status Post PCI, run by North Texas Veterans Healthcare System.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hazard Rate (time frame: 1 year follow ups). 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 NCT01665833, 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 15 Aug 2012.