SMART Trial Longitudinal Follow-Up:Off-Pump Versus On-Pum... | NCT00209053

Studies
SMART Trial Longitudinal Follow-Up:Off-Pump Versus On-Pump Coronary Artery Bypass Surgery

NCT00209053

Sponsor

Emory University

Status

Completed

Last Update Posted

Oct 16, 2013Estimated

Enrollment

87Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

Coronary Artery Bypass

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2013

Last Update Posted Date

Oct 16, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Puskas, MD, Professor, Emory UniversityPrincipal Investigator

Lead Sponsor

Emory UniversityOTHER

Collaborators

Name	Class
Medtronic	INDUSTRY
Boston Scientific Corporation	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to determine completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 initial trial participants at > 5 years post surgery who had heart bypass surgery with heart-lung bypass (on-pump) or without heart-lung bypass (off-pump). The hypothesis is that the patency of coronary artery bypass grafts of off-pump surgery are no less durable than grafts from conventional on-pump surgery.

Detailed Description

The Surgical Management of Arterial Revascularization Therapies (SMART) trial is a randomized, controlled, double blinded trial designed to compare completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 unselected patients referred for elective, isolated coronary bypass surgery and randomized to have coronary artery bypass performed with or without cardiopulmonary bypass. These patients were enrolled between March 2000 to August 2001.

The primary objective of this study is to test the hypothesis that the patency of coronary artery bypass grafts constructed during off-pump coronary artery bypass (OPCAB)are no less durable than the patency of those constructed during conventional CABG with cardiopulmonary bypass (CABG/CPB)after > 5 years of follow-up (non-inferiority hypothesis).

The secondary objectives are to determine whether there are differences between these randomized groups in the following outcomes measures at > 5 years:

Neurocognitive Function
Stroke/cerebral injury
Health-related quality of life
Myocardial perfusion and ischemia
Major Adverse Cardiac Events (MACE)
Cardiac Functional Status
Incidence and severity of angina
All cause mortality and cardiovascular mortality
Cost of hospital re-admissions since 1 year follow-up

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Off Pump CABG	Experimental	CABG without cardiopulmonary bypass.	Procedure: Coronary Artery Bypass
On-Pump CABG	Active Comparator	CABG with cardiopulmonary bypass.	Procedure: Coronary Artery Bypass

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coronary Artery Bypass	Procedure		Off Pump CABG On-Pump CABG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
after > 5 years, graft patency determined by non-invasive dual 64 slice multi-detector computed tomographic coronary angiography and cardiac positron emission tomography.		8 year follow-up

Secondary Outcomes

Measure	Description	Time Frame
Secondary outcomes will be measured by; a battery of neuropsychological tests, MRI, NIH stroke scale, questionnaires, cardiac PET scanning, NYHA and CCS classifications and Medicare DRG's.		8 year follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Referred for primary or re-operative elective coronary artery bypass graft (CABG) with coronary targets suitable for off-pump bypass graft and currently enrolled in Phase 1 of SMART Trial

Exclusion Criteria:

Emergent CABG
Required pre-operative intra-aortic balloon pump (IABP)
Cardiogenic shock
Evolving acute myocardial infarction
Coronary artery targets unsuitable for off-pump bypass surgery
Inability or unwillingness to provide informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John D Puskas, M.D.	Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory Healthcare/EmoryUniversity		Atlanta	Georgia	30308	United States

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001026	Coronary Artery Bypass

Ancestor Terms

ID	Term
D009204	Myocardial Revascularization
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided