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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Coronary CTA; Other: Stress MPI SPECT

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.

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110029
      • Department of cardiology, All India Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who have planned, elective invasive angiography, elective coronary revascularization, or MACE at 6 month and at 1-year follow up	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)	6 months and 1 year

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborators: Pontificia Universidad Catolica de Chile; International Atomic Energy Agency; University Hospital Ostrava; University Medical Centre Ljubljana; Ankara University; Fu Wai Hospital, Beijing, China; Universidad Nacional Autonoma de Mexico; Università degli Studi di Brescia; Centre Hospitalier Universitaire de Bab El Oued; Hospital Italiano Garibaldi,Rosario ARGENTINA; Instituto de Cardiologia,Bogota D.C. COLOMBIA; Instituto de Cardiologia y Cirugia Cardiovascular,LA Habana CUBA; Indian Institute of Public Health, India
• 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 Catolica 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 Cardiología y Cirugía Cardiovascular; Principal Investigator: Otakar Kraft, University Hospital; Principal Investigator: Niveditha Devasenapathy, Indian Institute of Public Health; Principal Investigator: Davide Farina, Università 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (ESTIMATE): June 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 2, 2015
• Last Update Submitted That Met QC Criteria: April 1, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: Protocol version 1.1; CTRI/2010/091/001384 (REGISTRY: Clinical Trial Registry of India)