An observational study in Coronary Artery Disease, Ischemic Heart Disease (IHD) and Myocardial Viability, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of Texas Southwestern Medical Center · Observational
Among 1,105 studies in Coronary Artery Disease with a site in United States — 102 open to participants now, 147 under way, 10 of them phase 3. Coronary Artery Disease · United States.
Among the 1,105 studies in Coronary Artery Disease with a site in United States, this one is the 294th largest by planned enrollment of the 357 observational ones that give a count, is one of 29 that started in 2023, is one of 358 observational ones, reaches primary completion later than 63 of the 144 other live ones, and was the 1,007th registered.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
Browse Coronary Artery Disease studies →102 of the 1,105 studies in Coronary Artery Disease with a site in United States are open now. Recruiting first, the newest first:
EBI Anti Sepsis BV · Sites in United States, Belgium, Netherlands and 1 more country
University of Colorado, Denver · Sites in United States
Verve Therapeutics, Inc. · Sites in United States
Novartis Pharmaceuticals · Sites in United States, Australia, Germany and 2 more countries
Minneapolis Heart Institute Foundation · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 20 Years to 80 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,105 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 50 · Phase 2 104 · Phase 3 112 · Phase 4 141
First in 1985; this study’s year is marked. 29 started in 2023.
This study's planned enrollment of 30 is below the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Median enrollment 107 across the 746 interventional studies, 186 across the 357 observational. Of the 838 that completed or were terminated, 355 (42%) have results posted.
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378 of 1,105 have an industry lead sponsor. The 10 most frequent:
University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
University of Texas Southwestern Medical Center has 6 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
52 of the studies in Coronary Artery Disease with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07357675Phase 3EBI Anti Sepsis BVA Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery. | 2027-10-01 |
| NCT06305559Phase 3NewAmsterdam PharmaA CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque | 2027-11 |
| NCT01114269Brigham and Women's HospitalPRE-DETERMINE Cohort Study | 2026-11 |
| NCT06713239Cleerly, Inc.A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CAD | 2026-12 |
| NCT03894423Stanford UniversityComprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery | 2026-12 |
Among the 1,105 studies in Coronary Artery Disease with a site in United States, from their registry updates:
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Heart failure due to coronary artery disease represents a significant cause of mortality. The detection of patients eligible for bypass surgery is a pivotal concern. Nevertheless, the optimal approach for patient selection based on conventional imaging scans remains unclear. The proposed method (Hyperpolarized 13C MRI) has gained extensive use in evaluating in vivo metabolism. This method avoids ionizing radiation and provides critical insights into cardiac function. The feasibility study aims to investigate this method for patient selection before bypass surgery. This innovative imaging technique facilitates the identification of two simple molecules, bicarbonate and lactic acid, produced at high rates by normal heart metabolism. Both bicarbonate and lactate originate from the same precursor molecule, pyruvate. The data generated from this study holds the potential to refine diagnostic precision.
PRIMARY OBJECTIVES:
The principal aim of this investigation is to employ noninvasive techniques for the in vivo assessment of segmental myocardial metabolism. This will be achieved by measuring the hyperpolarized (HP) 13C bicarbonate-to-lactate (bic/lac) ratio in patients scheduled for coronary artery bypass surgery (CABG), both preoperatively and 4-6 months postoperatively. These findings will be compared with a control group of healthy subjects to establish normal metabolic values.
SECONDARY OBJECTIVES:
In addition to the primary objectives, this study seeks to accomplish the following secondary objectives:
EXPLORATORY OBJECTIVES:
In pursuit of further insights, this research also aims to explore the following:
Potential human subjects will be identified and referred by cardiothoracic surgeons (Drs. Peltz or Jessen.) and their clinical team will discuss the opportunity to participate with their patients or potential subjects. A research nurse from the Cardiovascular and Thoracic Surgery Clinical Trials office will directly contact the subject to further discuss study participation, otherwise, the details and contact information of clinical study coordinator will be provided for prescreening. Once the study candidate expresses interest, details will be forwarded to the Advanced Imaging Research Center and an appointment will be scheduled for the 13C metabolic imaging exam. All NIH and UTSWMC regulations related to confidentiality, recruitment practices, etc., will apply. All patients will be reviewed for medical history, demographics, subject eligibility criteria, MRI screening form, informed consent, and pregnancy test for females of child-bearing potential.
The eligibility criteria for this feasibility study are designed to select participants who will provide valuable insights into myocardial metabolism using HP-13C MRI in various contexts related to ischemic heart failure. These criteria aim to ensure that the study population is diverse and representative of the patient groups under investigation.
Inclusion/Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy volunteers (male or female, aged 20-80 years) who are eligible for a 3T MRI. They must have no history of coronary artery disease, diabetes, or other exclusionary medical diagnoses.
Male or female patients (aged 20-80 years) who are scheduled for Coronary Artery Bypass Surgery as standard of care. These patients have 1, 2, or more stenotic coronary vessels and are eligible for a 3T MRI.
The same population of patients from the preoperative group undergoing a follow-up evaluation 4-6 months after their surgical coronary revascularization.
Bicarbonate-to-Lactate Ratio in Healthy Control Subjects
Assessment of normal segmental myocardial metabolism by measuring the ratio of hyperpolarized (HP) \[13C\]-bicarbonate to HP \[1-13C\]lactate (bic/lac ratio). This is obtained during an HP-13C MRI utilizing \[1-13C\] pyruvate to establish baseline normal values for healthy subjects.
Time frame: Baseline (Day 1 of imaging)
Bicarbonate-to-Lactate Ratio in Preoperative CAD Patients
Assessment of segmental myocardial metabolism and mechanical function in patients scheduled for coronary artery bypass surgery. The bic/lac ratio is measured using HP-13C MRI to identify abnormal cardiac metabolism and impaired oxidative function. These metabolic findings will be correlated with echocardiographic measurements of wall motion and viability studies obtained by the referring cardiologist.
Time frame: Preoperative imaging day
Change in Bicarbonate-to-Lactate Ratio Post-Surgery
Follow-up assessment of segmental myocardial metabolism to evaluate the remodeling of cardiac metabolism as a consequence of surgery. The bic/lac ratio is measured using HP-13C MRI to determine if the ratio has increased compared to the patient's preoperative baseline, indicating improved oxidative function.
Time frame: 4-6 months after surgical coronary revascularization
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Jun 2027, 47 months after the start.
Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 47 months is close to that.
Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
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University of Texas Southwestern Medical Center →