NCT01368770

Brief Summary

The use of coronary computed tomographic angiography(CTA)is rapidly increasing, but there is lack of data which supports their use in the initial evaluation of patients who are asymptomatic or mildly symptomatic. The hypothesis underlying this proposal is that the use of stress-rest myocardial perfusion imaging (MPI) as an initial test for the evaluation of asymptomatic or mildly symptomatic patients who are at intermediate risk of coronary events will result in less further non-invasive and invasive testing and result in reduced costs, without adversely affecting clinical outcomes in the short term.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
303

participants targeted

Target at P50-P75 for phase_3 coronary-artery-disease

Timeline
Completed

Started Jul 2011

Typical duration for phase_3 coronary-artery-disease

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

First Submitted

Initial submission to the registry

June 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 2, 2015

Status Verified

April 1, 2015

Enrollment Period

2.9 years

First QC Date

June 6, 2011

Last Update Submit

April 1, 2015

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients who have additional non-invasive testing with another modality, or invasive coronary angiography within 6 months of the first test.

    The primary objective is to compare the efficacy (in terms of reduced additional non-invasive or invasive testing) and costs (at 6 months) of a strategy of initial stress-rest MPI, to a strategy of initial coronary CTA in the management of asymptomatic patients at intermediate or high risk of coronary events by the Framingham criteria, or mildly symptomatic patients who are at intermediate likelihood of having CAD.

    6 months

  • Costs of investigation and treatment in both groups

    To compare costs between a strategy of initial stress-rest MPI with a strategy of initial coronary CTA in the management of asymptomatic patients at intermediate or high risk of coronary events by the Framingham criteria, or mildly symptomatic patients who are at intermediate likelihood of having CAD.

    6 months

Secondary Outcomes (1)

  • Proportion of patients who have planned, elective invasive angiography, elective coronary revascularization, or MACE at 6 month and at 1-year follow up

    6 months and 1 year

Study Arms (2)

Coronary CTA

EXPERIMENTAL

Coronary CTA using standard protocols

Other: Coronary CTAOther: Stress MPI SPECT

Stress MPI SPECT

ACTIVE COMPARATOR

Stress-rest MPI SPECT using standard protocols

Other: Coronary CTAOther: Stress MPI SPECT

Interventions

Coronary CTAOTHER

Coronary CTA using standard protocols

Coronary CTAStress MPI SPECT
Stress MPI SPECTOTHER

Stress MPI using standard protocols

Coronary CTAStress MPI SPECT

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consenting patients above 21 years who are mildly symptomatic (those in class II NYHA), who have an intermediate likelihood of CAD, or asymptomatic patients who are determined to be at intermediate or high risk of coronary events by the Framingham (ATP III) criteria

You may not qualify if:

  • Patients with prior documented CAD (by angiography), MI, coronary stenting or bypass surgery
  • Patients in class III or IV NYHA
  • Patients with chronic renal impairment to the extent of precluding contrast injection
  • Severe medical disease with limited expectancy of life
  • Contra-indication or allergy to pharmacologic stress agents or contrast agents
  • Patients with unstable cardiac rhythms (including persistent atrial fibrillation) which preclude good ECG gating
  • Weight limitations due to scanner design
  • Pregnant/ lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of cardiology, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (1)

  • Karthikeyan G, Guzic Salobir B, Jug B, Devasenapathy N, Alexanderson E, Vitola J, Kraft O, Ozkan E, Sharma S, Purohit G, Dolenc Novak M, Meave A, Trevethan S, Cerci R, Zier S, Gotthardtova L, Jonszta T, Altin T, Soydal C, Patel C, Gulati G, Paez D, Dondi M, Kashyap R. Functional compared to anatomical imaging in the initial evaluation of patients with suspected coronary artery disease: An international, multi-center, randomized controlled trial (IAEA-SPECT/CTA study). J Nucl Cardiol. 2017 Apr;24(2):507-517. doi: 10.1007/s12350-016-0664-3. Epub 2016 Oct 28.

    PMID: 27796852DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ganesan Karthikeyan, MD,DM,MSc

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Salah E Bouyoucef

    Centre Hospitalier Universitaire de Bab El-Qued

    PRINCIPAL INVESTIGATOR

  • Jorge Cachero

    Hospital Italiano Garibaldi

    PRINCIPAL INVESTIGATOR

  • Rodrigo J Fernández

    Universidad Católica de Chile

    PRINCIPAL INVESTIGATOR

  • Zuo X He

    Fu Wai Hospital, Beijing, China

    PRINCIPAL INVESTIGATOR

  • Claudia Teresa G Villamil

    Instituto de Cardiologia

    PRINCIPAL INVESTIGATOR

  • Amalia T Peix González

    Instituto de Cardiologia y Cirugia Cardiovascular

    PRINCIPAL INVESTIGATOR

  • Otakar Kraft

    University Hospital

    PRINCIPAL INVESTIGATOR

  • Niveditha Devasenapathy

    Indian Institute of Public Health

    PRINCIPAL INVESTIGATOR

  • Davide Farina

    Universita di Brescia

    PRINCIPAL INVESTIGATOR

  • Aloha Meave

    Universidad Nacional Autonoma de Mexico

    PRINCIPAL INVESTIGATOR

  • Barbara G Salobir

    University Medical Centre

    PRINCIPAL INVESTIGATOR

  • Borut Jug

    University Medical Centre

    PRINCIPAL INVESTIGATOR

  • Elgin Ozkan

    Ankara University

    PRINCIPAL INVESTIGATOR

  • Maurizio DONDI

    International Atomic Energy Agency

    PRINCIPAL INVESTIGATOR

  • Ravi KASHYAP

    International Atomic Energy Agency

    PRINCIPAL INVESTIGATOR

  • Diana PAEZ

    International Atomic Energy Agency

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor of Cardiology

Study Record Dates

First Submitted

June 6, 2011

First Posted

June 8, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

April 2, 2015

Record last verified: 2015-04

Locations

IN(1)