Comprehensive Cardiac CT Versus Exercise Testing in Suspe... | NCT02291484

Studies
Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2)

NCT02291484

Sponsor

Erasmus Medical Center

Status

Completed

Last Update Posted

Aug 4, 2016Estimated

Enrollment

250Actual

Phase

Phase 3

Conditions

Stable Angina Pectoris
Coronary Artery Disease

Interventions

Cardiac CT scan

Countries

Netherlands

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

Aug 2016

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

Aug 2013

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Nov 11, 2014

First Submission Date that Met QC Criteria

Nov 13, 2014

First Posted Date

Nov 14, 2014Estimated

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

Aug 3, 2016

Last Update Posted Date

Aug 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Koen Nieman, Dr K Nieman, Erasmus Medical CenterPrincipal Investigator

Lead Sponsor

Erasmus Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with standard stress testing in patients with stable chest pain complaints.

Detailed Description

Rationale: CT calcium and coronary lumen imaging allow efficient exclusion of coronary artery disease (CAD), but cannot assess the hemodynamic significance of obstructive findings. Addition of stress myocardial perfusion imaging, which assesses the functional relevance of coronary narrowing, completes the non-invasive cardiac evaluation.

Hypothesis: A comprehensive cardiac CT examination will allow fast, accurate and complete evaluation of suspected CAD.

Objective: evaluate the effectiveness and efficiency of comprehensive cardiac CT workup of suspected CAD.

Study design: Open-labelled, randomized-controlled, clinical efficiency trial, with an intention-to-diagnose approach, between CT-guided management and the current standard of care (based on functional testing of provocable myocardial ischemia) in patients with suspected CAD.

Study population: 250 patients (>18 yrs) with stable chest complaints, a >10% pre-test probability of CAD, and referred for evaluation of possible CAD.

Intervention: Instead of the usual diagnostic approach, patients in the intervention group will undergo in sequence the following CT examinations: coronary calcium scan, coronary CT angiography and CT myocardial perfusion imaging, with completion dependent on results. Findings on CT will direct further management.

Main study parameters/endpoints:

Primary: Rate of negative invasive angiograms (as percentage of total population) Secondary: Diagnostic yield, chest complaints, quality of life, diagnostic and therapeutic procedures, overall costs and adverse events at 6 months.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Comprehensive cardiac CT	Experimental	Tiered cardiac CT protocol: CT calcium scan CT angiography (if calcium scan positive or high pre-test probability) CT perfusion (if >50% stenosis on CTA, or cannot be ruled out)	Device: Cardiac CT scan
Standard care	No Intervention	Standard diagnostic management of suspected CAD, using stress testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac CT scan	Device	CT-guided management	Comprehensive cardiac CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of negative invasive angiograms (as percentage of total population)	Number of performed invasive angiograms with no CAD requiring intervention	6 months

Secondary Outcomes

Measure	Description	Time Frame
Chest pain complaints	Proportion of patients experiencing symptoms of chest pain	6 months
Quality of life	Questionnaire based quality of life score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women aged >18 years.
Chest pain symptoms suspicious of coronary heart disease.
Pre-test probability of coronary artery disease >10%

Exclusion Criteria:

History of CAD: prior myocardial infarction or revascularization procedure
Contra-indication to radiation exposure (CT/SPECT): pregnancy
Contra-indication to iodine contrast media: renal failure, iodine allergy
Contra-indications to adenosine
Inability or unwillingness to provide informed consent.

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
Koen Nieman, MD, PhD	Erasmus Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Albert Schweizerzieknhuis		Dordrecht		3318 AT	Netherlands
Maastricht University Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29248657	Derived	Lubbers M, Coenen A, Kofflard M, Bruning T, Kietselaer B, Galema T, Kock M, Niezen A, Das M, van Gent M, van den Bos EJ, van Woerkens L, Musters P, Kooij S, Nous F, Budde R, Hunink M, Nieman K. Comprehensive Cardiac CT With Myocardial Perfusion Imaging Versus Functional Testing in Suspected Coronary Artery Disease: The Multicenter, Randomized CRESCENT-II Trial. JACC Cardiovasc Imaging. 2018 Nov;11(11):1625-1636. doi: 10.1016/j.jcmg.2017.10.010. Epub 2017 Dec 13.

ID	Term
D060050	Angina, Stable
D003324	Coronary Artery Disease

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases