NOGA Angiogenesis Revascularization Therapy: Evaluation b... | NCT00143585

Studies
NOGA Angiogenesis Revascularization Therapy: Evaluation by RadioNuclide Imaging - The Northern Trial

NCT00143585

Sponsor

Unity Health Toronto

Status

Unknown status

Last Update Posted

Jul 25, 2008Estimated

Enrollment

120

Phase

Phase 2Phase 3

Conditions

Myocardial Ischemia

Interventions

intramyocardial delivery of either VEGF165 or placebo

Countries

Canada

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2002

Primary Completion Date

Not provided

Completion Date

Jun 2007Estimated

First Submitted Date

Sep 1, 2005

First Submission Date that Met QC Criteria

Sep 1, 2005

First Posted Date

Sep 2, 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

Jul 24, 2008

Last Update Posted Date

Jul 25, 2008Estimated

Description Module

Brief Summary

To demonstrate the clinical efficacy and safety of vascular endothelial growth factor(VEGF165)when delivered by direct myocardial injection through the NOGA navigational catheter to improve myocardial perfusion in patients with severe angina pectoris for whom conventional PCI or CABG are either not possible or not ideal.Secondary objective will be to determine the effects of VEGF gene therapy on angina symptoms, patient perceived quality of life and exercise capacity

Detailed Description

A multicentre, double blind, placebo controlled trial to assess efficacy of VEGF and promote myocardial angiogenesis in patients with CCS III-IV angina symptoms,treated with maximal anti anginal medications who are not amenable to or not ideal candidates for conventional revascularization.

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
intramyocardial delivery of either VEGF165 or placebo	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Myocardial perfusion-stress/ rest scores(SRS),changes in summed stress scores(SSS)from baseline to 12 weeks follow up between placebo and VEGF treated groups. This analysis will be repeated at 6 months

Secondary Outcomes

Measure	Description	Time Frame
symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Canadian Cardiovascular Class III-IV angina despite treatment with maximal medical therapy
LVEF>20%
Ischemic defects on myocardial stress SPECT imaging

Exclusion Criteria:

NYHA>2
History of or diagnosis of age related macular degeneration, retinopathy
Atrial fibrillation
Primary valvular heart disease
Evidence of or known history of cancer with in past 10 yea
Uncontrolled hypertension
Liability to receive dipyridamole
History or diagnosis of rheumatoid arthritis
Recent MI(within 4 weeks)
Important ilio-femoral peripheral vascular disease, limiting catheter access
History of unexplained gastrointestinal hemorrhage with the past 5 years
LV thrombus visualized by either echocardiography or contrast LV angiogram
Other severe concurrent illnesses

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Duncan J. Stewart, MD	Unity Health Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta		Edmonton	Alberta	T6G 2B7	Canada
Victoria Heart Institute Foundation

Type	Date	Date Unknown
Release	Sep 8, 2009
Reset	Oct 8, 2009
Release	Jul 30, 2015
Reset	Aug 28, 2015
Release	Oct 13, 2015
Reset	Nov 13, 2015
Release	Jan 12, 2016
Reset	Feb 10, 2016

Submission Tracking

Estimated Results First Submitted Date

Sep 8, 2009

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 8, 2009			Oct 8, 2009
Jul 30, 2015

Condition Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided