Status:

COMPLETED

Endothelial Modulation for Angiogenic Therapy

Lead Sponsor:

Ottawa Heart Institute Research Corporation

Collaborating Sponsors:

Heart and Stroke Foundation of Ontario

Conditions:

Coronary Artery Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

Coronary artery disease is the single most important killer of Canadians. Despite major advances in therapy, there is still a significant proportion of patients identified with the disease who die of ...

Detailed Description

The EMAT trial tests the hypothesis that the concomitant treatment of chronic endothelial dysfunction in patients undergoing angiogenic therapy can make angiogenesis clinically effective. This is achi...

Eligibility Criteria

Inclusion

  • Severe chronic angina
  • Multi-vessel coronary artery disease
  • Diffusely diseased left anterior descending coronary artery (LAD)
  • At least 18 years of age at the time of written informed consent

Exclusion

  • Pregnancy, lactation, or any child-bearing potential
  • Patients who are candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting
  • Severe left ventricular dysfunction (ejection fraction \< 30%)
  • Threatened proximal coronary occlusion or unstable angina
  • Recent myocardial infarction (\< 1 month)
  • Chronic renal failure (serum creatinine \> 130 µmol/L)
  • Hepatic insufficiency (Child-Pugh Class C)
  • Clinically significant valvular heart disease
  • Personal history of neoplasia
  • Abnormal serum prostate-specific antigen (PSA), bowel neoplasia screening questionnaire, or updated mammography report (if female) - any test not performed within the last 6 months will be conducted prior to confirmation of eligibility
  • Family history of cancer (i.e. ≥ 2 first-degree relatives)
  • History of diabetic retinopathy
  • Latent herpes infection
  • Schizophrenia
  • Claustrophobia

Key Trial Info

Start Date :

November 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2007

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00134433

Start Date

November 1 2004

End Date

October 1 2007

Last Update

June 21 2012

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Division of Cardiac Surgery, University of Ottawa Heart Institute

Ottawa, Ontario, Canada, K1Y 4W7