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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Subhash Banerjee, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01665833
First received: August 13, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Hazard Rate [ Time Frame: 1 year follow ups ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 13, 2012
Last Updated: August 13, 2012
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 22, 2013