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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368770
• Other study ID #: Protocol version 1.1
• Secondary ID: CTRI/2010/091/00
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2011
• Last updated: April 1, 2015
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical ResearchIndia: Institutional Review BoardIndia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Coronary CTA
Coronary CTA using standard protocols
• Stress MPI SPECT
Stress MPI using standard protocols

Locations

Country	Name	City	State
India	Department of cardiology, All India Institute of Medical Sciences	New Delhi	Delhi

Sponsors (14)

Lead Sponsor

Collaborator

All India Institute of Medical Sciences, New Delhi

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

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No