NCT05796739

Brief Summary

The purpose of the SMART-EXAM (SMart Angioplasty Research Team-Pragmatic Randomized Trial for Comparing Routine versus As-Needed EXercise or Pharmacologic Stress Testing in Asymptomatic Patients with High-Risk Coronary CalciuM) trial is to compare the major adverse cardiovascular events between routine stress testing and as-needed stress testing in asymptomatic patients with high-risk coronary calcium (Agatston Score ≥ 400) without proven ASCVD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jul 2023Dec 2029

First Submitted

Initial submission to the registry

March 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 3, 2023

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

6 years

First QC Date

March 21, 2023

Last Update Submit

January 12, 2025

Conditions

Coronary Atherosclerosis Due to Calcified Coronary Lesion

Keywords

Non-invasive stress testCoronary calcificationAgatston score

Outcome Measures

Primary Outcomes (1)

  • Occurrence of major adverse cardiovascular events

    a composite of death from cardiovascular causes, myocardial infarction, unplanned hospitalization leading to an urgent revascularization procedure, or heart failure hospitalization

    up to 4.5 years of median follow-up

Secondary Outcomes (12)

  • cardiovascular death

    up to 4.5 years of median follow-up

  • myocardial infarction

    up to 4.5 years of median follow-up

  • unplanned hospitalization leading to an urgent revascularization procedure

    up to 4.5 years of median follow-up

  • heart failure hospitalization

    up to 4.5 years of median follow-up

  • all-cause death

    up to 4.5 years of median follow-up

  • +7 more secondary outcomes

Study Arms (2)

Routine stress testing

EXPERIMENTAL

In this group, the preselected functional stress testing (exercise electrocardiography, stress echocardiography, nuclear imaging, or stress cardiac magnetic resonance imaging) will be performed within three months (± 2 months) according to the practice pattern of each participating center.

Diagnostic Test: Non-invasive stress test

As-needed stress testing

ACTIVE COMPARATOR

In this group, optimal medical treatment will be performed by current guidelines without further testing. A stress test will be performed only when new symptoms (exertional chest pain or dyspnea) occur that may clinically suggest significant coronary artery disease.

Diagnostic Test: Medical treatment without further testing

Interventions

Non-invasive stress testDIAGNOSTIC_TEST

Nuclear imaging, stress echocardiography, exercise electrocardiography, stress cardiac magnetic resonance imaging

Routine stress testing
Medical treatment without further testingDIAGNOSTIC_TEST

Optimal medical treatment for primary prevention.

As-needed stress testing

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be at least 19 years of age. ② Asymptomatic patients with high-risk coronary calcium (Agatston Score ≥ 400)

You may not qualify if:

  • Documentation of objective evidence of inducible ischemia before enrollment
  • Presence of significant coronary artery stenosis (≥ 70% diameter stenosis) confirmed by coronary angiography or coronary computed tomography angiography before enrollment
  • History of coronary revascularization procedure ④ Pregnancy or breast feeding ⑤ Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment) ⑥ Unwillingness or inability to comply with the procedures described in this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SamsungMedicalCenter

Seoul, 06351, South Korea

RECRUITING

Study Officials

  • Seung-Hyuk Choi, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Hyuk Choi, MD

CONTACT

82-2-3410-3419sh1214.choi@samsung.com

Ki Hong Choi

CONTACT

82-2-3410-6653cardiokh@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 3, 2023

Study Start

July 3, 2023

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

January 14, 2025

Record last verified: 2025-01

Locations

KR(1)