Myocardial InjuryNCT06382402
A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI
An observational study of Myocardial Injury, run by University of Louisville at 1 site in United States.
Trial summary
This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myocardial Injury
- What is being tested?
- CCTA scan
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients diagnosed with type 2 NSTEMI.
Who may be able to join
- Inpatient with type 2 NSTEMI
- Aged 18-70 years old
- At the University of Louisville and Jewish hospitals
Who cannot join
- History of severe or anaphylactic reaction to iodinated contrast
- Inability to cooperate with scan protocols
- Hemodynamic instability
- Decompensated heart failure
- Acute myocardial infarction
- Renal impairment with GFR < 30
Show all 12Show fewer
- Pregnancy
- Inability to tolerate heart rate-slowing medications or nitroglycerin
- Recent phosphodiesterase inhibitor use
- Severe aortic stenosis
- Bronchospastic disease
- Patient's weight and height
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville School of Medicine, Division of Cardiovascular Diseases
Louisville, Kentucky, 40202
About this study
Official title: Randomized Control Trial of Outcomes Comparing a Coronary Computed Tomography Angiography (CCTA) Guided Management Strategy Versus a Standard of Care Strategy in Type 2 Non-ST-elevation MI
This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI.
Read the detailed description
This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI. Patients are randomized into 2 groups. Group 1 undergoes coronary 64-detector row computed tomography angiography (CCTA) and Group 2 receives conservative management and treatment for underlying conditions. The investigators will evaluate cross-sectional and time-varying clinical, laboratory, and imaging characteristics in association with clinical events. The exclusion criteria are an absence of information for follow-up of clinical events, and patients who have absolute and relative contraindications for CCTA. Absolute contraindications are a patient history of severe or anaphylactic reaction to iodinated contrast, inability to cooperate with scan protocols, hemodynamic instability, decompensated heart failure, acute myocardial infarction, and renal impairment with GFR < 30. Relative contraindications include pregnancy, inability to tolerate heart rate-slowing medications or nitroglycerin, recent phosphodiesterase inhibitor use, severe aortic stenosis, bronchospastic disease, and patient's weight and height.
- Conditions
- Myocardial Injury
- Being tested
- CCTA scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTA scanRadiation
- CCTA will be performed per the standard clinical protocol using a Cannon Aquilion ONE scanner with 16 cm z-axis coverage at 0.5 mm resolution, low contrast, and reduced radiation dose requirements.
| Study group | Role | What they receive |
|---|---|---|
| CCTA Group | CT group will undergo CCTA to evaluate for coronary artery disease to early address underlying CAD and then care will be directed based on the findings of that CT scan. Receives: Radiation: CCTA scan | |
| No CCTA Group | Group 2 will not undergo CCTA and will be managed at the discretion of the primary team using the standard of care pathway comprising of either conservative medical management, stress testing, or invasive evaluation with coronary angiography in the catheterization laboratory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Time to the first major adverse cardiac event (MACE) at 3 years between 2 groups.
Unit: no unit (yes/no)
Measured: anytime within 3 years
Cardiovascular (CV) mortality
Cardiovascular (CV) mortality Unit: no unit (yes/no)
Measured: anytime within 3 years
Nonfatal MI, stroke
Nonfatal MI, stroke Unit: no unit (yes or no)
Measured: anytime within 3 years
Hospitalization for unstable angina
Hospitalization for unstable angina Unit: no unit (yes or no)
Measured: anytime within 3 years
Hospitalization for heart failure
Hospitalization for heart failure Unit: no unit (yes or no)
Measured: anytime within 3 years
Unplanned revascularization
Unplanned revascularization Unit: no unit (yes or no)
Measured: anytime within 3 years
Secondary outcomes (5)
All-cause mortality
All-cause mortality Unit: no unit (yes or no)
Measured: anytime within 3 years
In-hospital and 90-day costs
In-hospital and 90-day costs Unit: US dollars
Measured: anytime within 90 days
Patient quality of life at 90 days
Patient quality of life at 90 days Unit: The numeric rating scales
Measured: anytime within 90 days
Diagnostic certainty scores
Diagnostic certainty scores Unit: The numeric rating scores
Measured: anytime within 3 years
Individual components of the primary endpoint
Individual components of the primary endpoint Unit: no unit (yes or no)
Measured: anytime within 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 May 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Why it stopped: study withdrawn, no participant enrolled, change in the study design planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinesh Kalra, MD, University of Louisville
- Investigators
- Dinesh Kalra, MD, Principal investigator, University of Louisville School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382402
- Sponsor's protocol ID
- 23.0924
- Status last verified
- May 2024
- First submitted
- 19 Apr 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Outcomes Comparing a Coronary Computed Tomography Angiography (CCTA) Guided Management Strategy Versus a Standard of Care Strategy in Type 2 Non-ST-elevation MI
- ClinicalTrials.gov ID
- NCT06382402
- Acronym / sponsor ID
- 23.0924
- Conditions
- Myocardial Injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study withdrawn, no participant enrolled, change in the study design planned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI.
Detailed description
This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI. Patients are randomized into 2 groups. Group 1 undergoes coronary 64-detector row computed tomography angiography (CCTA) and Group 2 receives conservative management and treatment for underlying conditions. The investigators will evaluate cross-sectional and time-varying clinical, laboratory, and imaging characteristics in association with clinical events. The exclusion criteria are an absence of information for follow-up of clinical events, and patients who have absolute and relative contraindications for CCTA. Absolute contraindications are a patient history of severe or anaphylactic reaction to iodinated contrast, inability to cooperate with scan protocols, hemodynamic instability, decompensated heart failure, acute myocardial infarction, and renal impairment with GFR < 30. Relative contraindications include pregnancy, inability to tolerate heart rate-slowing medications or nitroglycerin, recent phosphodiesterase inhibitor use, severe aortic stenosis, bronchospastic disease, and patient's weight and height.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCTA Group | – | Radiation: CCTA scanCT group will undergo CCTA to evaluate for coronary artery disease to early address underlying CAD and then care will be directed based on the findings of that CT scan. |
| No CCTA Group | – | –Group 2 will not undergo CCTA and will be managed at the discretion of the primary team using the standard of care pathway comprising of either conservative medical management, stress testing, or invasive evaluation with coronary angiography in the catheterization laboratory. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients diagnosed with type 2 NSTEMI.
Key inclusion criteria (3 listed)
- Inpatient with type 2 NSTEMI
- Aged 18-70 years old
- At the University of Louisville and Jewish hospitals
Key exclusion criteria (12 listed)
- History of severe or anaphylactic reaction to iodinated contrast
- Inability to cooperate with scan protocols
- Hemodynamic instability
- Decompensated heart failure
- Acute myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTA scan• CCTA will be performed per the standard clinical protocol using a Cannon Aquilion ONE scanner with 16 cm z-axis coverage at 0.5 mm resolution, low contrast, and reduced radiation dose requirements. | Radiation | CCTA Group |
Primary outcome
MACE
Time frame: anytime within 3 years
Time to the first major adverse cardiac event (MACE) at 3 years between 2 groups. Unit: no unit (yes/no)
Cardiovascular (CV) mortality
Time frame: anytime within 3 years
Cardiovascular (CV) mortality Unit: no unit (yes/no)
Nonfatal MI, stroke
Time frame: anytime within 3 years
Nonfatal MI, stroke Unit: no unit (yes or no)
Hospitalization for unstable angina
Time frame: anytime within 3 years
Hospitalization for unstable angina Unit: no unit (yes or no)
Hospitalization for heart failure
Time frame: anytime within 3 years
Hospitalization for heart failure Unit: no unit (yes or no)
Unplanned revascularization
Time frame: anytime within 3 years
Unplanned revascularization Unit: no unit (yes or no)
5 secondary outcomes
All-cause mortality
Time frame: anytime within 3 years
In-hospital and 90-day costs
Time frame: anytime within 90 days
Patient quality of life at 90 days
Time frame: anytime within 90 days
Diagnostic certainty scores
Time frame: anytime within 3 years
Individual components of the primary endpoint
Time frame: anytime within 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dinesh Kalra, MD principal investigator
University of Louisville School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Injury, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: anytime within 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.