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New treatment option for Cardiovascular Diseases
Official title A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
ClinicalTrials.gov ID: NCT07286578
What this study is testing
- What it's testing
- The OPTIMAL randomized clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- The subject must be at least 18 years of age and younger than 85 years old
- Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal...
- All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm
- Subject must provide written informed consent before any study-related procedure
You likely can't join if
- STEMI as the clinical presentation.
- Uncontrolled or recurrent ventricular tachycardia.
- Hemodynamic instability.
- Hemodialysis or peritoneal dialysis.
- Left main coronary artery stenosis \> 50%
- Atrial fibrillation, flutter, or arrhythmias during CT acquisition.
See the full eligibility criteria
- The subject must be at least 18 years of age and younger than 85 years old
- Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for...
- All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm
- Subject must provide written informed consent before any study-related procedure
- STEMI as the clinical presentation.
- Uncontrolled or recurrent ventricular tachycardia.
- Hemodynamic instability.
- Hemodialysis or peritoneal dialysis.
- Left main coronary artery stenosis \> 50%
- Atrial fibrillation, flutter, or arrhythmias during CT acquisition.
- Previous PCI in the target vessel or CABG.
- BMI ≥ 40 kg/m2
- Insufficient CT quality assessed by the Core lab.
- Comorbidity with life expectancy ≤ 2 years.
- Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is...
- The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
- The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus...
- The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.
- Subject has a platelet count \ 700,000 cells/mm3.
- The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
- The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or...
- Subject is currently participating in another investigational drug or device clinical study.
- Pregnant or nursing people and those who plan pregnancy in the period up to 2 years following index procedure. Female people of child-bearing potential must have a negative pregnancy test done within 7 days prior to the...
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical...
- Unable to provide written informed consent (IC).
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Jersey City, New Jersey, United States
- New York, New York, United States
- Barcelona, Spain
- León, Spain
- Madrid, Spain
- Leicester, United Kingdom
- London, United Kingdom
- Newcastle, United Kingdom
- Oxford, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Minneapolis, Minnesota, United States; Jersey City, New Jersey, United States; New York, New York, United States; Barcelona, Spain; León, Spain and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.