A clinical trial to compare Stress-rest MIBI-SPECT test with Coronary CT Angiography test as the initial test in the evaluation of patients at intermediate risk of coronary(Heart related) events - A Pilot Randomized Controlled Trial (MIBI-SPECT - Methoxyisobutyl Isonitrile-Single Photon-Emission Computed Tomography; CT-Computerized Tomography)

Stress-rest MIBI-SPECT compared to Coronary CT Angiography as the initial test in the evaluation of patients at intermediate risk of coronary events - A Pilot Randomized Controlled Trial (IAEA SPECT/CT CAD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001384

Enrollment

500

Registered

2011-02-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Coronary artery disease

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 1. Consenting patients above 21 years who are asymptomatic or mildly symptomatic (those in class I or II NYHA) determined to be at intermediate risk of coronary events by the Framingham criteria. (NYHA-New York Heart Association grading)

Exclusion criteria

Exclusion criteria: 1. Patients with prior documented coronary artery disease, myocardial infarction, coronary stenting or bypass surgery 2. Patients with class III or IV NYHA. 3. Patients with chronic renal impairment to the extent of precluding contrast injection 4. Severe medical disease with limited expectancy of life 5. Contra-indication or allergy to pharmacologic stress agents or contrast agents 6. Patients with unstable cardiac rhythms (including persistent atrial fibrillation) which preclude good ECG gating 7. Weight limitations due to scanner design.

Design outcomes

Primary

Measure	Time frame
Proportion of patients who have additional non-invasive testing with another modality(rest-stress myocardial perfusion imaging, CT angiography, stress ECG, cardiac magnetic resonance imaging or stress ECHO)or invasive coronary angiography within 6 months of the first test. This is the primary outcome of the study. 2. Costs of investigation and treatment at 6 months in both groupsTimepoint: 6 months	—

Measure

Time frame

Proportion of patients who have additional non-invasive testing with another modality(rest-stress myocardial perfusion imaging, CT angiography, stress ECG, cardiac magnetic resonance imaging or stress ECHO)or invasive coronary angiography within 6 months of the first test. This is the primary outcome of the study. 2. Costs of investigation and treatment at 6 months in both groupsTimepoint: 6 months

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Secondary

Measure	Time frame
1. Proportion of patients who have planned, elective invasive angiography at 6 month follow up 2. Proportion of patients who have planned, elective coronary interventions or bypass surgery at 6 month and 1-year follow up 3. The occurrence of a composite of all cause mortality, nonfatal MI, recurrent ischemia or unplanned coronary revascularization at 6-month and 1-year of follow up 4. Among patients undergoing both MPI and CTA, - To correlate calcium score and the degree of stenosis on CTA with the amount of ischemia on MPI. - To correlate non-perfusion parameters with ischemia and anatomic findings. - To assess topographic correlation of ischemia and anatomic disease. Timepoint: 6 Months and 1 year	—

Measure

Time frame

1. Proportion of patients who have planned, elective invasive angiography at 6 month follow up 2. Proportion of patients who have planned, elective coronary interventions or bypass surgery at 6 month and 1-year follow up 3. The occurrence of a composite of all cause mortality, nonfatal MI, recurrent ischemia or unplanned coronary revascularization at 6-month and 1-year of follow up 4. Among patients undergoing both MPI and CTA, - To correlate calcium score and the degree of stenosis on CTA with the amount of ischemia on MPI. - To correlate non-perfusion parameters with ischemia and anatomic findings. - To assess topographic correlation of ischemia and anatomic disease. Timepoint: 6 Months and 1 year

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Countries

Algeria, Argentina, Chile, China, Colombia, Cuba, Czech Republic, India, Mexico, Slovenia, Turkey, United States of America

Contacts

Public ContactDr G Karthikeyen

All India Institute of Medical Sciences

karthik2010@gmail.com011-26594464

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026