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

NCT ID: NCT01665833

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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

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Angina Status Post PCI Status Post CABG

Keywords

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Angina SYNTAX Coronary PCI CABG

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Texas Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

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Subhash Banerjee

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Subhash Banerjee, MD

Role: PRINCIPAL_INVESTIGATOR

Dallas VA Medical Center

Emmanouil Brilakis, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Dallas VA Medical Center

References

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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.

Reference Type RESULT
PMID: 19228612 (View on PubMed)

Other Identifiers

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SYNTAX

Identifier Type: -

Identifier Source: org_study_id