Clinical trial NCT01368770: Stress Testing Compared to Coronary Computed Tomographic Angiography in Patients With Suspected Coronary Artery Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Bab El Oued
name: Hospital Italiano Garibaldi,Rosario ARGENTINA
name: Pontificia Universidad Catolica de Chile
name: Fu Wai Hospital, Beijing, China
name: Instituto de Cardiologia,Bogota D.C. COLOMBIA
name: Instituto de Cardiologia y Cirugia Cardiovascular,LA Habana CUBA
name: University Hospital Ostrava
name: Indian Institute of Public Health, India
name: Università degli Studi di Brescia
name: Universidad Nacional Autonoma de Mexico
name: University Medical Centre Ljubljana
name: Ankara University
name: International Atomic Energy Agency
First posted: 2011-06-08
Enrollment: 303
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Proportion of patients who have additional non-invasive testing with another modality, or invasive coronary angiography within 6 months of the first test.
timeFrame: 6 months
measure: Costs of investigation and treatment in both groups
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients who have planned, elective invasive angiography, elective coronary revascularization, or MACE at 6 month and at 1-year follow up
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Department of cardiology, All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Ganesan Karthikeyan, MD,DM,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Bab El-Qued
name: Salah E Bouyoucef
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Italiano Garibaldi
name: Jorge Cachero
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Católica de Chile
name: Rodrigo J Fernández
role: PRINCIPAL_INVESTIGATOR
affiliation: Fu Wai Hospital, Beijing, China
name: Zuo X He
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Cardiologia
name: Claudia Teresa G Villamil
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Cardiologia y Cirugia Cardiovascular
name: Amalia T Peix González
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital
name: Otakar Kraft
role: PRINCIPAL_INVESTIGATOR
affiliation: Indian Institute of Public Health
name: Niveditha Devasenapathy
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Brescia
name: Davide Farina
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Nacional Autonoma de Mexico
name: Aloha Meave
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Centre
name: Barbara G Salobir
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Centre
name: Borut Jug
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University
name: Elgin Ozkan
role: PRINCIPAL_INVESTIGATOR
affiliation: International Atomic Energy Agency
name: Maurizio DONDI
role: PRINCIPAL_INVESTIGATOR
affiliation: International Atomic Energy Agency
name: Ravi KASHYAP
role: PRINCIPAL_INVESTIGATOR
affiliation: International Atomic Energy Agency
name: Diana PAEZ
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.