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Angina, Stable clinical trials

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NCT ID: NCT06400290 Not yet recruiting - Stable Angina Clinical Trials

Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

ORBITA-MOON
Start date: May 2024
Phase: N/A
Study type: Interventional

ORBITA-MOON is a double-blinded, placebo-controlled experimental study that aims to understand how the different coronary artery stenoses contribute to overall clinical angina in patients with multi-vessel coronary artery disease. This study will investigate the symptoms conferred by each stenosis, induced by experimental ischaemia, for 60 patients with multi-vessel coronary artery disease.

NCT ID: NCT06387693 Not yet recruiting - Angina, Stable Clinical Trials

Artificial Intelligence in ANOCA

(AI)NOCA
Start date: August 2024
Phase: N/A
Study type: Interventional

Angina pectoris is diagnosed in >180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. This condition, angina with no obstructed coronary artery (ANOCA), is more prevalent in women and is related to poor quality of life, high medical expenses, and a higher incidence of adverse events. The origin of ANOCA can be evaluated during invasive coronary angiography by coronary function testing (CFT) to identify coronary vasomotor disorders. This relates to vasospasm of the coronary artery and microcirculation, or to impaired microvascular vasodilation. For the diagnosis of vasospasm, CFT needs to result in electrocardiographic signs of myocardial ischemia as part of the diagnostic criteria. This is a critical point in the diagnosis of vasospasm, as these signs can be subtle and can vary, and are therefore prone to misinterpretation. Apart from this caveat, the diagnosis approach therefore currently requires an invasive procedure for the diagnosis. This limits the broad application and hampers early identification and treatment of ANOCA. During CFT, a coronary guide wire is routinely advanced in the coronary artery which also allows obtaining an intracoronary ECG by attaching a sterile alligator clamp to a standard electrocardiogram lead. This allows continuous recording of intracoronary ECG throughout CFT on the same monitor as the routine ECG. This technique can increase sensitivity for myocardial ischemia during CFT. Further, Holter ECG monitoring allows the identification of ischemic changes in the ECG in the outpatient setting. Evidence is lacking on the patterns of myocardial ischemia that occur during spontaneous angina pectoris symptoms in ANOCA patients, and on the sensitivity of Holter ECG for this purpose. Finally, the interpretation of ischemic patterns on ECG tracings can be cumbersome, especially when changes are subtle or change from beat to beat. The use of deep learning techniques allows to automate the interpretation of ECG traces and may improve the standardized diagnosis in ANOCA.

NCT ID: NCT06325020 Not yet recruiting - Clinical trials for Coronary Artery Disease

Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology

ORACLE
Start date: May 1, 2024
Phase:
Study type: Observational

The ORACLE study is an observational cohort study designed to explore the feasibility of providing an assessment of chest pain for patients with suspected angina within one working day of referral to specialist services. The primary objective is to determine the feasibility of delivering an objective assessment of risk for participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in a community setting using point of care and patient facing technologies within one working day of referral. Participants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms. Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured by point of care high sensitivity cardiac troponin assays as well as a core lab assay. The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events.

NCT ID: NCT06311461 Recruiting - Angina, Stable Clinical Trials

Effects of Acupuncture on Symptoms of Stable Angina

EASE
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to determine if a standardized 12-point acupuncture protocol will reduce pain in participants with stable angina. This study addresses the critical need to reduce persistent pain for angina. The investigators long-term goal is symptom management for diverse women and men with angina, targeting additional angina burden borne of social disadvantage Participants will be randomized to a 10-acupuncture session protocol, two treatments per week for five weeks, or an attention control group. Participants will view designated, non-pain related Technology, Entertainment, Design Talks equal to the time spent receiving acupuncture (~7.5-10 hrs.). The investigators will test the efficacy of acupuncture for stable angina/chest pain syndrome to reduce pain and symptoms, improve health-related quality of life, reduce healthcare utilization and and improve patient related health outcomes.

NCT ID: NCT06298045 Recruiting - Stable Angina Clinical Trials

Effectiveness of a Combination of Trimetazidine With One Hemodynamic Agent in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy

Start date: July 15, 2023
Phase:
Study type: Observational

The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). The treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items (SAQ-7) Patients will be also proposed to complete a BEAMER (BEhavioral and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe) questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative (IMI). Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only.

NCT ID: NCT06249581 Active, not recruiting - Clinical trials for Chronic Stable Angina

Pharmacokinetics of AUX-001 40mg Once-daily in Healthy Subjects Under Fasting and Fed Conditions

Start date: November 27, 2023
Phase: Early Phase 1
Study type: Interventional

Exploratory, single-dose, open-label, pharmacokinetic study to establish uptake, plasma levels safety and tolerability of orally administered AUX-001 on an empty stomach (i.e, fasting) as well as after a meal (i.e. fed) in healthy volunteers.

NCT ID: NCT06224582 Completed - Clinical trials for Chronic Stable Angina

Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI

Start date: December 30, 2020
Phase: N/A
Study type: Interventional

A prospective, multi-center, double-blind, randomized, placebo-controlled trial is conducted to evaluate the efficacy and safety of Yinxingmihuan oral solution in the treatment of chest pain after percutaneous coronary intervention (PCI) in patients with stable angina. Patients should undergo at least 1-week standardized medical treatment phase before randomization. The primary end point is the 12-week angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ) subscales. The main secondary endpoint is the improvement of anxiety assessed by Hamilton Anxiety Scale (HAMA) to evaluate its effectiveness for chest pain caused by psychological factors.

NCT ID: NCT06186336 Not yet recruiting - Clinical trials for Coronary Artery Disease

Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque

FOCUS DL
Start date: February 2024
Phase:
Study type: Observational

The primary objective of this study is to assess the accuracy in terms of sensitivity, specificity, negative and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade.

NCT ID: NCT06183294 Active, not recruiting - Clinical trials for Stable Angina, Unstable Angina, NSTEMI

Evaluation of a Novel Non-Invasive Automated Fractional Flow Reserve Software System in Patients With Coronary Artery Disease

Start date: August 22, 2023
Phase:
Study type: Observational

This retrospective study will evaluate the coronary angiograms of approximately 100 patients who have undergone invasive angiography and fractional flow reserve (FFR). DICOM files of the angiograms will be analyzed on a secure computer within the cardiac catheterization laboratory using the AutocathFFR software to assess if invasive FFR measurements and automated computer analysis of FFR measurements correlate. AutocathFFR measurement per lesion will be compared to the gold standard, invasive FFR value, where an FFR ≤ 0.80 will be considered "positive", while an FFR > 0.8 will be considered "negative". The AutocathFFR value will be compared to the invasive FFR measurements. The sensitivity and specificity of the AutocathFFR will be calculated, as well as the AutocathFFR accuracy, positive predictive value and negative predictive value per lesion. Device success will be calculated as the ratio of completed versus initiated AutocathFFR index calculations. Usability of the AutocathFFR software will be evaluated using dedicated questionnaires to be completed by the user (cardiologists).

NCT ID: NCT06171893 Completed - Stress Clinical Trials

Assessing the Effect of the 'Wavy' Application, on Stress and Burden of Disease in Women With INOCA

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

For women that experience angina symptoms with underlying vascular spasm as the cause, stress has an aggravating role. Coping with stress is therefore included as an important pillar in dealing with this chronic disease, see the European Association of Percutaneous Cardiovascular Interventions (EACPI) consensus document on INOCA. In practice, stress management focuses on informing and identifying the role stress plays in their lives. A potential stress management tool: "Wavy" aims to help users manage stress more consciously through biofeedback. This research focuses on the effectiveness of stress management applications. The hypothesis is that the app will help to avoid the trigger stress as much as possible and thus reduce the burden of disease.