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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01368770
Enrollment
303
Registered
2011-06-08
Start date
2011-07-31
Completion date
2014-12-31
Last updated
2015-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

Coronary CTA using standard protocols

OTHERStress MPI SPECT

Stress MPI using standard protocols

Sponsors

Centre Hospitalier Universitaire de Bab El Oued
CollaboratorOTHER
Hospital Italiano Garibaldi,Rosario ARGENTINA
CollaboratorUNKNOWN
Pontificia Universidad Catolica de Chile
CollaboratorOTHER
Fu Wai Hospital, Beijing, China
CollaboratorOTHER
Instituto de Cardiologia,Bogota D.C. COLOMBIA
CollaboratorUNKNOWN
Instituto de Cardiologia y Cirugia Cardiovascular,LA Habana CUBA
CollaboratorUNKNOWN
University Hospital Ostrava
CollaboratorOTHER
Indian Institute of Public Health, India
CollaboratorOTHER
Università degli Studi di Brescia
CollaboratorOTHER
Universidad Nacional Autonoma de Mexico
CollaboratorOTHER
University Medical Centre Ljubljana
CollaboratorOTHER
Ankara University
CollaboratorOTHER
International Atomic Energy Agency
CollaboratorOTHER_GOV
All India Institute of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients who have additional non-invasive testing with another modality, or invasive coronary angiography within 6 months of the first test.6 monthsThe 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 groups6 monthsTo 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

MeasureTime frameDescription
Proportion of patients who have planned, elective invasive angiography, elective coronary revascularization, or MACE at 6 month and at 1-year follow up6 months and 1 yearTo 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)

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026