Multislice Spiral Computed Tomography and Cardiomyopathy | NCT00305916

Studies
Multislice Spiral Computed Tomography and Cardiomyopathy

NCT00305916

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Feb 26, 2008Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Cardiomyopathies

Interventions

Multislice spiral computed tomography coronary angiography
conventional coronary angiography

Countries

France

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

Feb 2008

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

Feb 2006

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Mar 21, 2006

First Submission Date that Met QC Criteria

Mar 21, 2006

First Posted Date

Mar 22, 2006Estimated

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

Feb 22, 2008

Last Update Posted Date

Feb 26, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with idiopathic cardiomyopathy. The aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with idiopathic cardiomyopathy in sinus rhythm, compared to conventional coronary angiography.

Detailed Description

The principal aim of this study is to assess the diagnostic accuracy (sensitivity, specificity, predictive values) of multislice spiral computed tomography (MSCT) coronary angiography among patients having idiopathic hypokinetic dilated cardiomyopathy in sinus rhythm, compared to conventional coronary angiography. The secondary aims are to assess the performance of MSCT in coronary sinus anatomy assessment, and in quantitative measurement of left ventricular anatomical criteria (telediastolic diameter, septal and posterior wall thickness, and ejection fraction) compared to echocardiography. Lastly, renal tolerance of MSCT will be studied. This prospective monocentric study will include 120 patients scheduled to undergo coronary angiography for etiologic diagnosis of idiopathic cardiomyopathy (defined by a left ventricle echographic ejection fraction ≤ 40 %, without anamnestic or electrocardiographic arguments in favour of coronary artery disease) in sinus rhythm. MSCT will be performed within 3 months after conventional coronary angiography, with blinded analysis.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	conventional coronary angiography	Procedure: conventional coronary angiography
2	Experimental	multislice spiral computed tomography coronary angiography	Procedure: Multislice spiral computed tomography coronary angiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multislice spiral computed tomography coronary angiography	Procedure		2	MSCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of > 50% coronary stenosis		During assessment
Sensibility, specificity, positive and negative predictive values of MSCT		During assessment

Secondary Outcomes

Measure	Description	Time Frame
Detection of patients with one or more coronary stenosis		During assessment
Detection of patients with 3-vessel disease		During assessment
Left ventricle telediastolic diameter

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients scheduled to undergo coronary angiography,
etiologic diagnosis of idiopathic cardiomyopathy (defined by a left ventricle echographic ejection fraction ≤ 40 %, without anamnestic or electrocardiographic arguments in favour of coronary artery disease),
in sinus rhythm,
informed written consent.

Exclusion Criteria:

allergy to iodine,
history of coronary artery bypass graft,
history of percutaneous coronary angioplasty,
history of myocardial infarction,
known coronary artery disease,
Q waves on the ECG,
unstable haemodynamic status,
urgent revascularisation or urgent valvular surgery,
heart rate > 80 bpm (before MSCT),
pregnancy,
enrollment in another study.
severe renal or respiratory insufficiency.

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
Dominique Boulmier, MD	Rennes University Hospital	Principal Investigator
Bruno Laviolle, MD	Rennes University Hospital	Study Chair
David Veillard, MD	Rennes University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou		Rennes		35033	France

Condition Browse Module

MeSH Terms

ID	Term
D009202	Cardiomyopathies

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
CIC0203/045
LOC/04-05