Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
ID05796739

SMART-EXAM Trial Comparing Routine Versus As-Needed Stress Testing in Asymptomatic Patients With High-Risk Coronary Calcium

Led by Samsung Medical Center · Updated on 2025-01-14

3000

Participants Needed

1

Research Sites

339 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the effects of routine stress testing versus stress testing only when needed in adults who have high-risk coronary calcium deposits but no symptoms or diagnosed atherosclerotic cardiovascular disease (ASCVD). The study focuses on people with an Agatston Score of 400 or higher, which indicates significant coronary artery calcium. Coronary artery calcium scanning is used to detect early signs of coronary artery disease and has been linked to future heart problems and death, regardless of traditional risk factors. Guidelines currently recommend calcium scoring only for certain risk groups, but it is increasingly used by the general public for self-assessment. Participants will be assigned to either receive routine non-invasive stress tests—including nuclear imaging, stress echocardiography, exercise electrocardiography, or stress cardiac MRI—or to receive optimal medical treatment without further testing. The purpose is to assess whether routine stress testing can better prevent major adverse cardiovascular events compared to testing as needed. The study includes a median follow-up period of up to 4.5 years to monitor outcomes. During the study, researchers will track the occurrence of major adverse cardiovascular events over the follow-up period. Participants will receive medical evaluations and monitoring based on their assigned group. The study will measure how often serious heart problems occur in both groups, aiming to understand the best approach for managing asymptomatic patients with high coronary calcium scores. The total participation time varies with the median follow-up of 4.5 years to observe long-term effects.

CONDITIONS

Official Title

Routine Versus As-Needed Stress Testing in Asymptomatic Patients With High-Risk Coronary Calcium

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 19 years old
  • Asymptomatic with high-risk coronary calcium (Agatston Score 64 400)
Not Eligible

You will not qualify if you...

  • Evidence of inducible ischemia before enrollment
  • Significant coronary artery stenosis (70% or more) confirmed before enrollment
  • History of coronary revascularization procedure
  • Pregnancy or breastfeeding
  • Non-cardiac conditions with life expectancy less than 1 year or that may cause non-compliance
  • Unwillingness or inability to follow study procedures

AI-Screening

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Trial Site Locations

Total: 1 location

1

SamsungMedicalCenter

Seoul, South Korea, 06351

Actively Recruiting

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Research Team

S

Seung-Hyuk Choi, MD

K

Ki Hong Choi

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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