NCT00755248

Brief Summary

The purpose of this study is to determine the relations between conventional and unconventional risk factors and adverse clinical events at follow-up (including coronary bypass patency) in patients undergoing surgical myocardial revascularization.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

September 18, 2008

Status Verified

September 1, 2008

First QC Date

September 16, 2008

Last Update Submit

September 16, 2008

Conditions

Keywords

Coronary Artery Bypass Grafting (CABG)outcomesaphenous graft patencybiochemical factorsgenomics

Study Arms (1)

1

Pts undergoing CABG or OPCAB

Procedure: Coronary Artery Bypass Grafting

Interventions

Coronary Artery Bypass Grafting on- or off-pump

1

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women age 18 to 89
  • Elective primary CABG
  • Female patients must be non-lactating and not pregnant
  • Able and willing to comply with study requirements by signing a consent form

You may not qualify if:

  • Concomitant surgery
  • Major end organ dysfunction
  • Serious intercurrent illness or infection
  • Known coagulation disorders
  • Emergencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino

Milan, Milan, 20138, Italy

RECRUITING

Related Publications (1)

  • 1. American Heart Association. Heart disease and stroke statistics - 2005 update. Dallas, TX: AHA 2004 2. Lytle BW. Prolonging patency - choosing coronary bypass grafts. N Engl J Med 2004; 351: 2262-4 3. Motwani JG et al. Aortocoronary saphenous vein graft disease : pathogenesis, predisposition and prevention. Circulation 1998; 97:916-31 4. Yilmaz M et al. Metabolic syndrome negatively impacts early patency of saphenous vein grafts. Coronary artery disease 2006; 17:41-4 5. Moor E et al. Haemostatic function in patients undergoing coronary artery bypass grafting: perioperative perturbations and relations to saphenous vein graft closure. Thrombosis research 2000; 98:39-49 6. Podgoreanu M et al. New paradigms in cardiovascular medicine. JACC 2005; 46:1965-77 7. Stafford-Smith M et al. Association of genetic polymorphisms with risk of renal injury after coronary bypass graft surgery. Am J Kidney Dusease 2005; 45:519-30 8. Moor E et al. Coagulation factor V (Arg506à Gln) mutation and early saphenous graft occlusion after coronary artery bypass grafting. Thromb Haemost 1998; 80:220-4 9. Yende S et al. Clinical relevance of ACE gene polymorphisms topredict risk of mechanical ventilation after coronary artery bypass surgery. Crit Care Med 2004; 32: 922-27

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma,serum, whole blood

MeSH Terms

Conditions

Atherosclerosis

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Alessandro Parolari, MD, PhD

    Centro Cardiologico Monzino - Milano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Parolari, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 18, 2008

Study Start

January 1, 2007

Study Completion

January 1, 2011

Last Updated

September 18, 2008

Record last verified: 2008-09

Locations