Cuff and calm: new combo aims to boost heart health
NCT ID NCT07514624
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether using a blood-pressure cuff device (called chronic remote ischemic conditioning) along with mindfulness audio sessions can improve blood flow to the heart in people with coronary artery disease who couldn't have all blockages opened. About 480 adults with chest pain and partially treated arteries will be randomly assigned to the combo treatment or a control. The main goal is to see if heart blood flow improves after 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chronic remote ischemic conditioning (a device that squeezes the arm with a blood-pressure cuff) and mindfulness therapy (guided audio sessions)
- What this could lead to
- If it works, this could offer a non-drug way to improve heart blood flow and reduce chest pain or heart events in people with partially treated coronary artery disease.
- What could go wrong
- This trial hasn't started yet, and it's a Phase NA study with 480 participants. The combination approach is new, so benefits are uncertain, and the device may cause discomfort or bruising.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 480 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years old * Consistent with the diagnosis of coronary heart disease, complete revascularization was not performed (coronary angiography showed that at least one vessel with a reference diameter of 3.0mm had stenosis greater than 90%, and quantitative flow ratio (QFR) \< 0.80) * Symptoms of myocardial ischemia (resting or exertional angina; Angina allele: chest tightness, shortness of breath, etc.); Exclusion Criteria: * • Age \< 18 years old * Heart failure patients with NYHA class IV, or left ventricular ejection fraction (LVEF) \< 30% * Creatinine clearance \<15 mL/min (or eGFR \< 15 mL/min/1.73m²), or requires dialysis * Myocardial diseases such as hypertrophic cardiomyopathy, dilated cardiomyopathy, etc. * Uncontrolled or recurrent arrhythmic events (e.g., ventricular fibrillation, recurrent or symptomatic sustained ventricular tachycardia, complete heart block, atrial fibrillation with rapid ventricular rates, supraventricular tachycardia refractory to drugs) * Poorly controlled hypertension (SBP \> 180 mm Hg or DBP \> 110 mm Hg) * Active liver disease or persistent ALT or AST elevation ≥ 3 times the upper limit of normal * Unexplained CK \> 5 times the upper limit of normal, or elevated CK due to known muscle disease * Planned or anticipated cardiac surgery or revascularization before randomization * History of active malignancy (surgery, radiation therapy, and/or systemic therapy within the past 3 years) * Diagnosed or suspected upper extremity vascular malformations, aneurysms, arteriovenous fistulas, or thrombosis * Hearing impairment, unable to undergo mindfulness therapy * Currently participating in another drug or device study, or within 30 days of completing another drug or device study or receiving another investigational drug * Any life-threatening comorbid conditions expected to result in death within the next year (excluding cardiovascular diseases) * Alcoholism, substance abuse history; and unwilling or unable to stop alcohol or substance abuse during the study * History of major organ transplant (e.g., lung, liver, heart, bone marrow, kidney) * Investigator's judgment of known major active and uncontrolled disease, or any medical, physical, or surgical conditions (e.g., infection, significant blood, kidney, metabolic, gastrointestinal, or endocrine dysfunction) that may interfere with participation in the clinical study * As known to the investigator, the subject is unlikely to complete follow-up for more than 1 year or is expected to be unable to comply with the study requirements or understand the study's objectives and potential risks.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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