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

Angina Clinical Trial

Official title:

A Retrospective Analysis Determining the Impact of Coronary Anatomy on Angina Relief in Patients Undergoing Coronary

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665833
• Other study ID #: SYNTAX
• Status: Completed
• Phase: N/A
• First received: August 13, 2012
• Last updated: August 13, 2012
• Start date: January 2003
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000000
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Angina
• Angina Pectoris
• Status Post CABG
• Status Post PCI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

References & Publications (1)

Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hazard Rate	Primary and secondary endpoints	1 year follow ups	No