NCT02161081

Brief Summary

Among the current myocardial CT perfusion techniques, dynamic CT perfusion technique is most advantageous in obtaining information on myocardial blood flow and volume. However, dynamic CT perfusion technique involves higher radiation dose than static CT techniques. Patients have to take a breath hold during 30 seconds with current dynamic CT perfusion protocol. If patients cannot hold their breath, anterior or inferior myocardium might be excluded due to limited scan coverage of a 128-slice dual-source CT scanner. Reduction of scanning duration of dynamic CT perfusion may not only reduce radiation exposure, but also make patients more comfortable. Therefore, the investigators intended to propose a modified scan protocol with shorter scan duration and compare diagnostic accuracy of a modified scan protocol with the current scan protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 6, 2017

Status Verified

March 1, 2014

Enrollment Period

1.9 years

First QC Date

March 31, 2014

Last Update Submit

December 5, 2017

Conditions

Myocardial Ischemia

Keywords

Myocardial ischemiaCoronary artery diseaseMyocardial CT perfusionModified scan protocolDiagnostic performanceRadiation dose

Outcome Measures

Primary Outcomes (1)

  • AUC (area under the curve) of CT perfusion for detection of perfusion defects : 30-second scanning protocol versus 21-second scanning protocol

    There were no significant differences in the diagnostic performances between two CTP protocols with different scan duration.

    When all randomized patients underwent CT scanning (A total of 120 symptomatic patients will be randomized to dynamic CT perfusion protocols with 30-second or 21-second scan duration.)

Secondary Outcomes (1)

  • Effective radiation dose for each component of the CT examination is calculated as the product of the dose-length product multiplied by a conversion coefficient of 0.014 (mSv/[mGycm]).

    up to 1 week after each patient underwent CT scanning

Study Arms (2)

Myocardial CT perfusion (21-second)

EXPERIMENTAL

A total of 60 symptomatic patients will be randomized to dynamic CT perfusion protocol with 21-second scan duration.

Procedure: Myocardial CT perfusion

Myocardial CT perfusion (30-second)

ACTIVE COMPARATOR

A total of 60 symptomatic patients will be randomized to dynamic CT perfusion protocol with 30-second scan duration.

Procedure: Myocardial CT perfusion

Interventions

Myocardial CT perfusionPROCEDURE

Adenosine-stress dynamic myocardial CT perfusion using 128-slice dual-source CT

Myocardial CT perfusion (21-second)Myocardial CT perfusion (30-second)

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women patients, with age ranging 30-80.
  • Known or suspected coronary artery disease who are supposed to undergo invasive coronary angiography
  • Patients who are willing to sign the informed consent form

You may not qualify if:

  • Contraindication of CT
  • Known allergy to iodinated contrast media or history of contrast-induced nephropathy
  • Decreased renal function: elevated serum creatinine (\>1.5 mg/dl)
  • Severe arrhythmia: atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block)
  • Severe thyroid disease
  • Homocystinuria
  • History of asthma
  • Hypersensitivity to adenosine
  • Severe obstructive lung disease
  • Intake of caffeine or xanthine-containing compounds within the last 48 hours
  • Contraindication of MRI
  • Claustrophobia
  • Metallic hazards
  • Pacemaker implant
  • eGFR (estimated glomerular filtration rate) \<30 ml/min
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Myocardial IschemiaCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Yeon Hyeon Choe, M.D.,Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

June 11, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

July 1, 2014

Last Updated

December 6, 2017

Record last verified: 2014-03

Locations

KR(1)