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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Other: Coronary CTA
Other: Stress MPI SPECT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 500
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coronary CTA
Coronary CTA using standard protocols
Other: Coronary CTA
Coronary CTA using standard protocols
Other: Stress MPI SPECT
Stress MPI using standard protocols
Active Comparator: Stress MPI SPECT
Stress-rest MPI SPECT using standard protocols
Other: Coronary CTA
Coronary CTA using standard protocols
Other: Stress MPI SPECT
Stress MPI using standard protocols

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368770

Contacts
Contact: Ganesan Karthikeyan, MD,DM,MSc +91-11-26593322 karthik2010@gmail.com
Contact: Maurizio Dondi, MD +43-1-2600-21670 m.dondi@iaea.org

Locations
India
Department of cardiology, All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: Ganesan Karthikeyan, MD, DM    +91-11-26594681    karthik2010@gmail.com   
Contact: Maurizio Dondi, MD    +43-1-2600-21670    m.dondi@iaea.org   
Principal Investigator: Ganesan Karthikeyan, MD, DM         
Sponsors and Collaborators
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
Investigators
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
  More Information

No publications provided

Responsible Party: Dr Ganesan Karthikeyan, Additional Professor of Cardiology, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01368770     History of Changes
Other Study ID Numbers: Protocol version 1.1, CTRI/2010/091/001384
Study First Received: June 6, 2011
Last Updated: October 23, 2013
Health Authority: India: Indian Council of Medical Research
India: Institutional Review Board
India: Ministry of Health

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014