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Impact of Coronary Anatomy on Angina Relief in Patients Undergoing Coronary Revascularization

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01665833
First Posted: August 15, 2012
Last Update Posted: August 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Subhash Banerjee, North Texas Veterans Healthcare System
  Purpose
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.

Condition
Angina Status Post PCI Status Post CABG

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Retrospective Analysis Determining the Impact of Coronary Anatomy on Angina Relief in Patients Undergoing Coronary

Resource links provided by NLM:


Further study details as provided by Subhash Banerjee, North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • Hazard Rate [ Time Frame: 1 year follow ups ]
    Primary and secondary endpoints


Enrollment: 4000000
Study Start Date: January 2003
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665833


Sponsors and Collaborators
North Texas Veterans Healthcare System
Investigators
Principal Investigator: Subhash Banerjee, MD Dallas VA Medical Center
Principal Investigator: Emmanouil Brilakis, MD,PhD Dallas VA Medical Center
  More Information

Publications:
Responsible Party: Subhash Banerjee, MD, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT01665833     History of Changes
Other Study ID Numbers: SYNTAX
First Submitted: August 13, 2012
First Posted: August 15, 2012
Last Update Posted: August 15, 2012
Last Verified: August 2012

Keywords provided by Subhash Banerjee, North Texas Veterans Healthcare System:
Angina
SYNTAX
Coronary
PCI
CABG

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms