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

NCT ID: NCT01368770

Last Updated: 2015-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-12-31

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Coronary CTA

Coronary CTA using standard protocols

Group Type: EXPERIMENTAL

Coronary CTA

Intervention Type: OTHER

Coronary CTA using standard protocols

Stress MPI SPECT

Intervention Type: OTHER

Stress MPI using standard protocols

Stress MPI SPECT

Stress-rest MPI SPECT using standard protocols

Group Type: ACTIVE_COMPARATOR

Coronary CTA

Intervention Type: OTHER

Coronary CTA using standard protocols

Stress MPI SPECT

Intervention Type: OTHER

Stress MPI using standard protocols

Interventions

Coronary CTA

Coronary CTA using standard protocols

Intervention Type: OTHER

Stress MPI SPECT

Stress MPI using standard protocols

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Bab El Oued

OTHER

Sponsor Role: collaborator

Hospital Italiano Garibaldi,Rosario ARGENTINA

UNKNOWN

Sponsor Role: collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: collaborator

Fu Wai Hospital, Beijing, China

OTHER

Sponsor Role: collaborator

Instituto de Cardiologia,Bogota D.C. COLOMBIA

UNKNOWN

Sponsor Role: collaborator

Instituto de Cardiologia y Cirugia Cardiovascular,LA Habana CUBA

UNKNOWN

Sponsor Role: collaborator

University Hospital Ostrava

OTHER

Sponsor Role: collaborator

Indian Institute of Public Health, India

OTHER

Sponsor Role: collaborator

Università degli Studi di Brescia

OTHER

Sponsor Role: collaborator

Universidad Nacional Autonoma de Mexico

OTHER

Sponsor Role: collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role: collaborator

Ankara University

OTHER

Sponsor Role: collaborator

International Atomic Energy Agency

OTHER_GOV

Sponsor Role: collaborator

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr Ganesan Karthikeyan

Additional Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ganesan Karthikeyan, MD,DM,MSc

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Salah E Bouyoucef

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Bab El-Qued

Jorge Cachero

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano Garibaldi

Rodrigo J Fernández

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica de Chile

Zuo X He

Role: PRINCIPAL_INVESTIGATOR

Fu Wai Hospital, Beijing, China

Claudia Teresa G Villamil

Role: PRINCIPAL_INVESTIGATOR

Instituto de Cardiologia

Amalia T Peix González

Role: PRINCIPAL_INVESTIGATOR

Instituto de Cardiologia y Cirugia Cardiovascular

Otakar Kraft

Role: PRINCIPAL_INVESTIGATOR

University Hospital

Niveditha Devasenapathy

Role: PRINCIPAL_INVESTIGATOR

Indian Institute of Public Health

Davide Farina

Role: PRINCIPAL_INVESTIGATOR

Universita di Brescia

Aloha Meave

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional Autonoma de Mexico

Barbara G Salobir

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre

Borut Jug

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre

Elgin Ozkan

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Maurizio DONDI

Role: PRINCIPAL_INVESTIGATOR

International Atomic Energy Agency

Ravi KASHYAP

Role: PRINCIPAL_INVESTIGATOR

International Atomic Energy Agency

Diana PAEZ

Role: PRINCIPAL_INVESTIGATOR

International Atomic Energy Agency

Locations

Department of cardiology, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 27796852 (View on PubMed)

Other Identifiers

CTRI/2010/091/001384

Identifier Type: REGISTRY

Identifier Source: secondary_id

Protocol version 1.1

Identifier Type: -

Identifier Source: org_study_id