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Myocardial Ischemia clinical trials

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NCT ID: NCT06045039 Recruiting - Clinical trials for Cardiovascular Diseases

Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions

Start date: January 1, 2023
Phase:
Study type: Observational

The treatment of coronary bifurcation lesions continue to remain challenges. Due to the special hemodynamics caused by the special anatomical structure of the coronary bifurcation, it is easy to cause vascular crest displacement and plaque formation. The existing single-stent strategy and double-stent strategy are easy to cause vascular crest offset, stent accumulation, in-stent thrombosis, in-stent restenosis and other poor long-term prognosis. Stent-balloon-stent (Stent-balloon-stent, SBS) technique enables the guide wire to enter the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm².The SBS technique reduces the risk of branch vascular dissection, occlusion, snow shoveling phenomenon, maintain the original state of bifurcated blood vessels to the greatest extent, should have a good impact on the long-term prognosis of patients with coronary bifurcation lesions (CBL). The purpose of this study is to explore the feasibility, safety and effectiveness of SBS technique.

NCT ID: NCT06033014 Recruiting - Clinical trials for Ischemic Heart Disease

Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease

PM Heart
Start date: September 18, 2023
Phase: N/A
Study type: Interventional

The PM-Heart algorithm (PMHeartIHD) is an in-house developed software that predict the survival prognosis for the individual patient hospitalized with ischemic heart disease (IHD) after a coronary arteriography has been performed. The software is intended to be used as a clinical decision support system i.e. the calculated survival prognosis is expected to enhance the quality of the treating physician's therapeutic considerations concerning (minor) adjustments to the patients treatment and follow-up - all within the framework of the current medical guidelines. Thus, the algorithm does not "show the physician specifically what to do", but rather ensures a better knowledgebase for the overall interpretation and choice of management of the patient.

NCT ID: NCT06031844 Recruiting - Clinical trials for Coronary Heart Disease

A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease

Start date: October 16, 2023
Phase: Phase 2
Study type: Interventional

This Phase 2a clinical trial will evaluate the effectiveness, safety, and tolerability of increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in approximately 24 people with known heart disease and an elevated marker of inflammation, hsCRP.

NCT ID: NCT06030596 Recruiting - Clinical trials for Coronary Artery Disease

SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve

Start date: September 9, 2022
Phase:
Study type: Observational

Recent evidences have demonstrated improved diagnostic accuracy for detecting coronary artery disease (CAD) when myocardial blood flow (MBF) is quantified in absolute terms using single photon emission tomography (SPECT) compared to conventional myocardial perfusion imaging (MPI). However, there are no uniformly accepted cutoff values of MBF and MFR derived from SPECT for diagnosing hemodynamically significant CAD. Particularly, the diagnostic performance for quantitative SPECT has not been validated using fractional flow reserve (FFR). The aim of this prospective study is to determine optimal cutoff values of absolute MBF and MFR derived from NaI (Tl)-based SPECT and to evaluate the diagnostic efficacy of this quantitative technology utilizing invasive coronary angiography (ICA) in combination with FFR results as the reference standard in patients with suspected or known CAD.

NCT ID: NCT06029777 Recruiting - Clinical trials for Coronary Artery Disease

Peri-luminal COROnary CTa AI-driven radiOMICS to Identify Vulnerable Patients (CORO-CTAIOMICS)

CORO-CTAIOMICS
Start date: July 31, 2023
Phase:
Study type: Observational

CAD is a leading cause of mortality in Europe. cCTA is recommended to rule out obstructive CAD, but, in most patients, it shows non-obstructive CAD. The management of these patients is unclear due to lack of reproducible quantitative measurement, beyond stenosis severity, capable to assess the risk of disease progression towards developing MACEs. To improve identification and phenotypization of patients at high risk of disease progression, we propose the application of artificial intelligence algorithms to cCTA images to automatically extract periluminal radiomics features to characterize the atherosclerotic process. By leveraging machine-learning empowered radiomics we aim to improve patients' risk stratification in a robust, quantitative and reproducible fashion. By developing a novel quantitative AI based cCTA measure, we expect to provide a risk score capable to identify patients who can benefit of a more aggressive medical treatment and management, thus improving outcome

NCT ID: NCT06025994 Recruiting - Clinical trials for Coronary Artery Disease

Standardizing the Management of Patients With Coronary Microvascular Dysfunction

SAMCRO
Start date: October 10, 2023
Phase: N/A
Study type: Interventional

The SAMCRO is an all comers, prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of outcomes (PROBE). The diagnosis of angina in non obstructive coronary artery disease (ANOCA) will be confirmed with coronary artery angiography and with the invasive assessment of coronary microvascular dysfunction (CMD) and coronary vasomotion. At least 120 ANOCA patients with invasively confirmed CMD will be randomized to i) multi-domain lifestyle intervention (experimental arm) vs. ii) standard of care (control arm). All patients will undergo follow-up visits at 6, 12, 24, 36, 48 and 60 months. The study endpoints will be the improvement of angina status and quality of life as assessed by validated questionnaires at one year. All participants in the multi-domain lifestyle group will receive five different kinds of intervention: i) dietary counselling, ii) strict management of cardiovascular (CV) and metabolic risk factors, iii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iv) exercise training and v) psychological intervention. Patients randomized to the control group will be managed according to current guidelines. The angina status will be assessed by the Seattle Angina Questionnaire (SAQ). Quality of life will be assessed using the EuroQoL (EQ5D-5L). Anxiety and depression will be assessed using the Beck Depression Inventory (BDI).

NCT ID: NCT06013722 Recruiting - Atherosclerosis Clinical Trials

Strategy for Unstable Coronary Plaque in Patients Presenting to Emergency Department for Chest Pain Suspected of Coronary Artery Disease

SPECTRE
Start date: March 18, 2024
Phase: N/A
Study type: Interventional

Primary prevention of coronary disease and especially its major complication, inaugural myocardial infarction, is based on any prodromal symptoms identification and on risk profile establishment. About 50% of myocardial infarctions are caused by an unstable non-stenosing plaque, asymptomatic before the event since without significant reduction in coronary flow, particularly during a stress test or during stress imaging. Study purpose is to set up, in medical emergency department, check-up unit and cardiology department, a primary prevention strategy articulated around a routine examination: calcium scoring. The latter makes it possible to categorize patients according to their risk of generating atheromatous plaques and to classify them into several risk levels (groups) according to their score: low (<40th percentile), intermediate (between the 40th percentile and the 65th percentile: group III) or high risk (>65th percentile, group IV). 18F-Na PET scan can mark unstable coronary plaques. For the intermediate risk population who would demonstrate within 6 to 18 months after first calcium score either an increase of percentile of more than 20% or an increase above 20 points of the calcium score and for high risk population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary prevention treatment will then be administered in the event of an abnormal examination.

NCT ID: NCT06002932 Recruiting - Clinical trials for Coronary Artery Disease

Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.

PROVISIONDEB
Start date: September 8, 2023
Phase: N/A
Study type: Interventional

[The Purpose of the Clinical Study] The purpose of this randomized comparison study is to compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients with non-LM coronary true-bifurcation lesions. [Hypothesis] In this study, the researchers intend to verify the hypothesis that the 1-stent strategy with a drug-eluting balloon is non-inferior to the 2-stent strategy in terms of target lesion failures (cardiac death, target vessel MI, or target vessel revascularization).

NCT ID: NCT05996120 Recruiting - Clinical trials for Cardiovascular Diseases

Study on Optimal Temperature During Cardiopulmonary Bypass (THERMIC-4)

THERMIC-4
Start date: May 20, 2024
Phase: N/A
Study type: Interventional

In order to perform heart surgery, a machine called cardiopulmonary bypass (CPB), or more commonly known as a heart-lung machine, is used to maintain the circulation of oxygenated blood needed by the rest of the body and its organs. Historically, when a patient is connected to CPB, their body is cooled below the normal body temperature. This is known as hypothermia. This is because scientific studies have previously shown that reduced body temperature lowers metabolism and therefore offers more protection to the brain and other organs due to the reduced oxygen requirement. The evidence supporting this practice, however, has been challenged throughout the history of cardiac surgery, with studies supporting that normothermia, or normal body temperature, is a safe alternative. Despite this, the practice of hypothermia has persisted. Published data from a survey of 139 cardiac surgeons in the United Kingdom showed that 84% still routinely employ hypothermic CPB during surgery. To assess whether normothermic or hypothermic CPB is safer, a clinical trial requiring a large sample size and high recruitment rates will be required. Therefore, the investigators aim to assess firstly the feasibility of trial recruitment and allocation adherence in this study. 100 adults across 10 different cardiac surgery centres in the United Kingdom will be recruited to a multicentre feasibility randomised controlled trial comparing normothermia (active comparator) against hypothermia (control comparator) during cardiopulmonary bypass in cardiac surgery. This study will also test the ability of the Cardiothoracic Interdisciplinary Research Network (CIRN), a trainee-led research collaborative, to collect pilot data on Major Adverse Cardiac and Cerebrovascular Events (MACCE) using a regulation-approved electronic application HealthBitⓇ. Participants will also be asked to complete quality of life surveys. The results of this study will subsequently inform a large, adequately powered randomised controlled trial for optimal temperature management during CPB.

NCT ID: NCT05994014 Recruiting - Clinical trials for Coronary Artery Disease

PET/CT* vs. Cardiac CT for Detecting Coronary Atherosclerotic Disease [*PET: Positron Emission Tomography; CT: Computed Tomography]

PET; CT
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Early detection of coronary atherosclerotic disease facilitates adequate prevention. The purpose of this study is to compare an assessment of coronary atherosclerotic disease burden by positron emission tomography / computed tomography (NaF-PET/CT) with those of conventional and ultra-high-resolution-CT (UHR-CT) in patients with suspected coronary artery disease. For this purpose, the investigators plan to include 33 patients with symptoms concerning for CAD who have been referred for cardiac CT testing.