A Comparison of Advanced Imaging Techniques in Aortic Ste... | NCT01775215

Studies
A Comparison of Advanced Imaging Techniques in Aortic Stenosis

NCT01775215

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Status

Withdrawn

Last Update Posted

Dec 2, 2014Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Aortic Stenosis

Interventions

Cardiac I123-MIBG Scintigraphy
Cardiac MRI
Stress and rest Echocardiogram
High Sensitivity Troponin I
Brain Natriuretic Peptide

Countries

United Kingdom

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

Nov 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Abandoned

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Jan 22, 2013

First Submission Date that Met QC Criteria

Jan 22, 2013

First Posted Date

Jan 24, 2013Estimated

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

Nov 27, 2014

Last Update Posted Date

Dec 2, 2014Estimated

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

In patients with aortic stenosis the valve through which blood is pumped out of the main heart chamber is narrowed. This results in heart muscle working harder to open the valve so blood can circulate around the body. The muscle adapts to the increased pressure load to maintain efficiency. This can cause long-term muscle damage. To predict when this deterioration will require a valve replacement is difficult and untimely operation exposes patients to unnecessary risk.

We aim to compare all validated techniques looking at different aspects of heart muscle strain in these patients. These will be a blood sample measuring a specific hormone (BNP) and enzyme (Troponin), a nuclear scan to assess nerve activation, an MRI identifying scarring and an exercise echocardiogram that measures heart muscle response and pressure changes across the valve. Tests will be performed at recruitment and either after one year or after valve replacement, which ever comes first.

In comparing these different imaging techniques we aim to identify patients who will benefit from an early operation, those whose muscle is likely to recover back to normal and which patients it is safe to wait longer for the surgery, avoiding unnecessary risk.

The results of the study will benefit patients as it will help doctors more accurately assess the timing of valve surgery and improve their prediction of long term heart muscle recovery. It may also increase convenience in clinical management by reducing unnecessary tests and hospital trips. This would translate into cost savings for the NHS.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A - Symptomatic severe AS		Patients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement.	Radiation: Cardiac I123-MIBG Scintigraphy Other: Cardiac MRI Other: Stress and rest Echocardiogram Other: High Sensitivity Troponin I Other: Brain Natriuretic Peptide
B - Asymptomatic moderate to severe AS		Asymptomatic patients with moderate to severe aortic stenosis (AS) as per ESC guidelines ,with Left Ventricular ejection fraction >50%, not yet requiring aortic valve replacement.	Radiation: Cardiac I123-MIBG Scintigraphy Other: Cardiac MRI Other: Stress and rest Echocardiogram Other: High Sensitivity Troponin I Other: Brain Natriuretic Peptide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac I123-MIBG Scintigraphy	Radiation		A - Symptomatic severe AS B - Asymptomatic moderate to severe AS
Cardiac MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Need for aortic valve replacement		1 year

Secondary Outcomes

Measure	Description	Time Frame
Improvement in measured indices post aortic valve replacement		6 months

Other Outcomes

Measure	Description	Time Frame
The change in rate of measured indices over time		6 months - 1 year
The relative change in measured indices between each other over time		6 months - 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(Group A)

Asymptomatic patients with moderate to severe Aortic Stenosis
Ejection fraction greater than 50%
Not yet being considered for valve surgery

(Group B)

Severe Aortic Stenosis (as per ESC guidelines)
Listed for immediate aortic valve replacement

Exclusion Criteria: (Group A and B)

Inability to provide informed consent
Concurrent primary valve lesions greater than mild (as defined by ESC criteria)
Previous myocardial infarction (regional wall motion abnormality on resting echo)
Cardiomyopathy
Congenital heart disease
Previous cardiac surgery
Renal failure (CKD stage 3, eGFR >30ml/min/1.73m2)
Pregnancy, risk of pregnancy, breast feeding

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

Tertiary care Outpatient population under regular follow by either cardiology or cardio thoracic team.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Kelion, MRCP DM	Royal Brompton and Harefield NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Harefield Hospital		London		UB9 6JH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020097	Natriuretic Peptide, Brain

Ancestor Terms

ID	Term
D045265	Natriuretic Peptides
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided