Stress Testing Compared to Coronary Computed Tomographic Angiography in Patients With Suspected Coronary Artery Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by All India Institute of Medical Sciences, New Delhi
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Bab El-Qued,Alger ALGERIA
Hospital Italiano Garibaldi,Rosario ARGENTINA
Pontificia Universidad Catolica de Chile
Beijing Fuwai Hospital,Beijing CHINA
Instituto de Cardiologia,Bogota D.C. COLOMBIA
Instituto de Cardiologia y Cirugia Cardiovascular,LA Habana CUBA
University Hospital,Ostrava Czech Republic
Indian Institute of Public Health,New Delhi India
Università degli Studi di Brescia
Universidad Nacional Autonoma de Mexico
University Medical Centre Ljubljana
Ankara University
International Atomic Energy Agency
Information provided by (Responsible Party):
Dr Ganesan Karthikeyan, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01368770
First received: June 6, 2011
Last updated: October 23, 2013
Last verified: October 2013

June 6, 2011
October 23, 2013
July 2011
June 2014   (final data collection date for primary outcome measure)
  • Proportion of patients who have additional non-invasive testing with another modality, or invasive coronary angiography within 6 months of the first test. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.
  • Costs of investigation and treatment in both groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01368770 on ClinicalTrials.gov Archive Site
Proportion of patients who have planned, elective invasive angiography, elective coronary revascularization, or MACE at 6 month and at 1-year follow up [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
To compare these two strategies in terms of the incidence of planned coronary angiography, revascularization and adverse clinical outcomes at 1 year (death, nonfatal MI, recurrent ischemia or unplanned coronary revascularization)
Proportion of patients who have planned, elective invasive angiography, elective coronary revaescularization, or MACE at 6 month and at 1-year follow up [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
To compare these two strategies in terms of the incidence of planned coronary angiography, revascularization and adverse clinical outcomes at 1 year (death, nonfatal MI, recurrent ischemia or unplanned coronary revascularization)
Not Provided
Not Provided
 
Stress Testing Compared to Coronary Computed Tomographic Angiography in Patients With Suspected Coronary Artery Disease
Stress-rest Single Photon-Emission Computed Tomography(SPECT)Compared to Coronary Computed Tomographic Angiography in the Initial Evaluation of Patients With Suspected Coronary Artery Disease-A Pilot Randomized Controlled Trial

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.

Recently coronary computed tomographic angiography (CTA) has become increasingly popular as a means of investigating asymptomatic or mildly symptomatic patients, instead of stress-rest myocardial perfusion imaging (MPI), despite the absence of long-term prognostic data. With its high negative predictive value, CTA has become useful for exclusion of CAD in patients with chest pain syndromes. However, the clinical management of a patient with an abnormal CTA is not well defined. Further, several caveats remain regarding the use of coronary CTA. Despite the anatomic data provided by CTA, it does not yield information regarding the functional consequences of the obstruction. Moreover, this technique may miss small vessel disease because of limited resolution and may not be useful in the presence of significant vessel calcium or coronary stents. Most importantly, there is no long-term data regarding the prognostic ability of coronary CTA in the initial evaluation of patients at intermediate risk of coronary events. An abnormal CTA result often leads to additional functional testing or invasive coronary angiography. The major drawback of performing two or more tests in tandem is that it greatly adds to cost that can be prohibitive in lower and middle income countries. Therefore, there is a need to determine if either stress MPI or CTA performed initially, results in meaningful differences in costs without adversely affecting clinical outcomes.

The primary objective of this pilot study is to compare the efficacy (in terms of reduced additional non-invasive or invasive testing) and costs of a strategy of initial stress-rest MPI, to a strategy of initial coronary CTA in the management of asymptomatic or mildly symptomatic patients who are at intermediate risk of coronary events (death or nonfatal MI) by the Framingham criteria.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
  • Other: Coronary CTA
    Coronary CTA using standard protocols
  • Other: Stress MPI SPECT
    Stress MPI using standard protocols
  • Experimental: Coronary CTA
    Coronary CTA using standard protocols
    Interventions:
    • Other: Coronary CTA
    • Other: Stress MPI SPECT
  • Active Comparator: Stress MPI SPECT
    Stress-rest MPI SPECT using standard protocols
    Interventions:
    • Other: Coronary CTA
    • Other: Stress MPI SPECT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
21 Years and older
No
Contact: Ganesan Karthikeyan, MD,DM,MSc +91-11-26593322 karthik2010@gmail.com
Contact: Maurizio Dondi, MD +43-1-2600-21670 m.dondi@iaea.org
India
 
NCT01368770
Protocol version 1.1, CTRI/2010/091/001384
No
Dr Ganesan Karthikeyan, All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
  • Centre Hospitalier Universitaire de Bab El-Qued,Alger ALGERIA
  • Hospital Italiano Garibaldi,Rosario ARGENTINA
  • Pontificia Universidad Catolica de Chile
  • Beijing Fuwai Hospital,Beijing CHINA
  • Instituto de Cardiologia,Bogota D.C. COLOMBIA
  • Instituto de Cardiologia y Cirugia Cardiovascular,LA Habana CUBA
  • University Hospital,Ostrava Czech Republic
  • Indian Institute of Public Health,New Delhi India
  • Università degli Studi di Brescia
  • Universidad Nacional Autonoma de Mexico
  • University Medical Centre Ljubljana
  • Ankara University
  • International Atomic Energy Agency
Principal Investigator: Ganesan Karthikeyan, MD,DM,MSc All India Institute of Medical Sciences, New Delhi
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 Beijing Fuwai Hospital
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
All India Institute of Medical Sciences, New Delhi
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP