NCT01856504

Brief Summary

To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Geographic Reach
5 countries

7 active sites

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

May 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 3, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

May 15, 2013

Last Update Submit

March 31, 2015

Conditions

Coronary Artery DiseaseCoronary Arteriosclerosis

Keywords

Heart DiseaseCoronary Artery DiseaseCoronary Arteriosclerosis

Outcome Measures

Primary Outcomes (3)

  • Diagnostic Accuracy

    To compare the per-patient, per-vessel and per-segment diagnostic accuracy of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.

    30 days

  • Diagnostic Interpretability

    To compare the per-patient, per-vessel and per-segment diagnostic interpretability of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.

    30 days

  • Image quality

    To compare the per-patient, per-vessel and per-segment quantitative image quality of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.

    30 day

Secondary Outcomes (2)

  • Upper threshold of heart rate

    1 day

  • incremental & additive value

    1 day

Study Arms (1)

CCTA Patient

1. Consenting adult patients ≥18 years of age; 2. Suspected but without known prior history of CAD 3. Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin) 4. Glomerular filtration rate \>60 ml/min 5. CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consenting adult patients ≥18 years of age, Suspected but without known prior history of CAD, Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin)

You may qualify if:

  • Consenting adult patients ≥18 years of age;
  • Suspected but without known prior history of CAD
  • Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin)
  • Glomerular filtration rate \>60 ml/min
  • CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization)

You may not qualify if:

  • Incomplete ICA or CCTA;
  • Known CAD (prior myocardial infarction, PCI, CABG)
  • Atrial Fibrillation
  • Abnormal Renal Function (GFR \<60 ml/min)
  • Unwilling or unable to give consent
  • Non-cardiac illness with life expectancy \<1 year
  • Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
  • Pregnant women
  • Allergy to iodinated contrast agent
  • Contraindications to nitroglycerin
  • Systolic blood pressure ≤90 mm Hg
  • Contraindications to β blockers or nitroglycerin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

MDDX

San Francisco, California, 94104, United States

Location

Walter Reed Medical Center

Bethesda, Maryland, United States

Location

Midwest Cardiology Associates

Independence, Missouri, United States

Location

Diagnostico Maipu

San Isidro, Argentina

Location

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

FACTS

Hyderabad, India

Location

Centro Cardiologico Monzino

Monzino, Italy

Location

MeSH Terms

Conditions

Coronary Artery DiseaseHeart Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 17, 2013

Study Start

May 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 3, 2015

Record last verified: 2015-03

Locations

IN(1)IT(1)AR(1)CA(1)US(3)