Clinical Research Directory

Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI

Adults who have had an ST-elevation myocardial infarction and were treated with stent placement will receive an intravenous infusion of a monoclonal antibody in order to prevent further heart muscle damage. The goal is to learn if this treatment improves some measures of heart function and inflammation. The study treatment patients will be compared to patients who receive placebo (inactive treatment).

Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction

This study is open to adults with ST elevation myocardial infarction (heart attack) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study is to determine whether a medicine called Xolatryp is safe and effective in improving cardiac outcomes. One dose of Xolatryp will be tested in this study. Participants are put into two groups randomly, which means by chance. One group receives a single 6-hour continuous intravenous infusion of Xolatryp and one group receives placebo. Participants are in the study for about 30 days. Placebo infusion looks like Xolatryp but do not contain any medicine. Participants are followed up via telephone and there is one visit to the study site on day 30. Heart health is assessed based on the analysis of blood samples, which are collected at the study site, via electrocardiogram (ECG), echocardiogram and cardiac magnetic resonance (CMR) imaging. At the end of the study, the results are compared between the two groups. During the study, the doctors also regularly check the general health of the participants.

Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study

This is a Phase IIb, multicentric, prospective, randomized (1:1 ratio), open label, and no profit study, with the aim of evaluating the efficacy of late INa current inhibition to improve coronary microcirculation in patients presenting with acute myocardial infarction and multivessel disease. All consecutive patients presenting with acute MI undergoing primary PCI (pPCI) on a major coronary artery, and with at least one remaining angiographically significant (% diameter stenosis \> 50%) non-culprit stenosis will be enrolled. The primary objective of the study is to evaluate the potential effect of Ranolazine in preserving coronary microcirculation subtended to the culprit vessel as compared with control group. Coronary microcirculation will be assessed both at the time of the culprit lesion revascularization and within 6+/-2 weeks by measuring the Index of Microcirculatory Resistance (IMR) either invasively or derived by the angiography (angioIMR). In addition, the following secondary endpoints will be assessed: 1. The prevalence of residual CMD downstream to the culprit vessel in all patients (CMDculprit). CMDculprit will be defined as the finding of an IMR/angioIMR value \> 25, assessed after successful pPCI. 2\. The prevalence of CMD downstream to the non-culprit vessel in the two group of patients (CMDnon-culprit). CMDnon-culprit will be defined as the finding of an IMRnon-culprit or an angioIMRnon-culprit value \> 25. IMRnon-culprit or angioIMRnon-culprit will be assessed at the time of staged PCI of the non-culprit stenosis. 3\. The incidence of peri-procedural CMD after staged PCI of the non-culprit stenoses, defined as a 20% increase of IMR values assessed before and after elective PCI of the non-culprit vessel (CMDprocedural). 4\. The difference between the two groups of patients, in terms of incidence of periprocedural Myocardial Infarction (PMI), eventually occurring during the staged procedure. 5\. The effects of INa current inhibition on endothelial function assessed at follow up as compared with control group. 6\. The extent of the Infarct Size, as assessed by the CMR, as compared with control group. 7\. The incidence of MACE, defined as composite of death, myocardial infarction, periprocedural MI, or any unplanned percutaneous coronary revascularization at short (42+/-7 days) term follow-up. 8\. Angina symptoms and quality of life

Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone

In patients with a myocardial infarction (MI) treated medically alone, the objective of the PANTHEON trial is to evaluate if ticagrelor monotherapy reduces bleeding events, without an increase in patient-oriented ischemic events, compared with standard dual antiplatelet therapy (DAPT) with aspirin and ticagrelor for 12 months.

DCB vs. DES in Young STEMI Patients: The DCB-STEMI Trial

Background: ST Elevation Myocardial Infarction (STEMI) in young adults (\<50 yrs) carries high Percutaneous coronary intervention (PCI) risks. While drug-eluting stents (DES) reduce restenosis versus angioplasty, they increase risks of in-stent restenosis, thrombosis, prolonged dual antiplatelet therapy (DAPT), and endothelial dysfunction. Drug-coated balloons (DCB) provide a "leave nothing behind" strategy, potentially mitigating these issues. Evidence, including a JACC CVI report, suggests DCB outcomes comparable to DES in STEMI. South Asia faces a heavy burden. The national Institute of Cardiovascular diseases (NICVD), Karachi performed 17,761 primary PCIs in 2022, with 45% in patients \<50 yrs. Study Design: This single-center Randomized Controlled Trial (RCT) compares paclitaxel-coated DCB (3.0 µg/mm², 30s inflation) vs. Drug eluting stents (DES) in young STEMI patients (\<50 yrs) undergoing primary PCI. The primary endpoint is 1-year vessel oriented cardiac events (VOCE)= Cardiovascular /all-cause death, target vessel MI, or Target lesion revascularization (TLR). Secondary endpoints include vessel-oriented CV events, bleeding, TIMI III flow, residual stenosis, abrupt closure, and bailout stenting. An intravascular ultrasound (IVUS) substudy (100 DCB pts) will evaluate remodeling and late lumen loss (LLL) at 6 months. Methods: 496 patients (248/arm) will be randomized 1:1, powered for non-inferiority (margin 4.5%) assuming VOCE 8.5% (DES) vs. 6.25% (DCB), 80% power, and 5% dropout. Inclusion: age 18-50, STEMI. Exclusion: End stage renal disease (ESRD), severe multivessel disease, complex lesions, or high thrombus burden. All will receive ticagrelor 90 mg BID for 1 month. A pilot of 50 pts will first assess safety (abrupt closure, lesion prep). Analysis: Intention-to-treat (ITT) will be primary; modified ITT for secondary endpoints. Statistics include chi-square/Fisher for categorical, t-test/Wilcoxon for continuous, and Kaplan-Meier/Cox for survival. Oversight by data safety monitoring board (DSMB) and Events adjudication Committee (EAC). Significance: This trial leverages NICVD's high PCI volume to test DCB as an alternative to DES in young STEMI patients. By avoiding permanent implants, DCB may reduce long-term complications and DAPT needs. The IVUS substudy and pilot phase strengthen rigor. If non-inferiority is proven, DCB could reshape STEMI management in South Asia and similar high-burden regions.

Randomised EValuation of Therapies for microvAscuLar Injury in STEACS

The goal of this interventional study is to evaluate if the CoFI system can act as a platform for intracoronary infusion of therapeutic agents to treat and relieve microvascular injury in ST Elevation Acute Coronary Syndrome (ACS) subjects diagnosed with MicroVascular Obstruction (MVO) after Primary Percutaneous Intervention (PPCI) and to quantify (identify) markers of treatment efficacy for CoFI mediated therapeutic agents infusion versus control. The targeted population is subjects presenting with an ST elevation myocardial infarction and undergoing PPCI as per standard of care. Enrolled STEMI subjects will be examined for MVO with the CoFI system. Primary endpoint of the study is EF by TTE at 6 months. If detected with MVO with the CoFI system, the subjects will be randomized and will receive treatment with medicinal product(s).

COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable

The COR-INSIGHT trial aims to evaluate the effectiveness of Peerbridge COR advanced ambulatory ECG wearables (COR 1.0 and COR 2.0) in accurately and non-invasively detecting cardiovascular and cardiopulmonary conditions using AI-based software (CardioMIND and CardioQSync). The study devices offer non-invasive, multiplexed, AI-enabled direct-from-ECG detection as a novel alternative to traditional diagnostic methods, including imaging, hemodynamic monitoring systems, catheter-based devices, and biochemical assays. Continuous COR ECG data collected in hospital, outpatient clinic, or home settings will be analyzed to evaluate the predictive accuracy, sensitivity, specificity, and performance of these devices in differentiating between screen-positive and screen-negative subjects. The panel of screened indications encompasses a broad spectrum of clinically relevant cardiovascular, cardiopulmonary, and sleep-related diagnostic parameters, which are critical for advanced patient assessment and management. In the cardiovascular domain, the protocol emphasizes the detection and classification of heart failure, assessment of ejection fraction severity, and identification of myocardial infarction, including pathological Q-waves and STEMI. It further addresses diagnostic markers for arrhythmogenic conditions such as QT interval prolongation, T-wave alternans, and ventricular tachycardia, as well as insights into ischemia, atrial enlargement, ventricular activation time, and heart rate turbulence. Additional parameters, such as heart rate variability, pacing efficacy, electrolyte imbalances, and structural abnormalities, including left ventricular hypertrophy, contribute to comprehensive cardiovascular risk stratification. In the non-invasive cardiopulmonary context, the protocol incorporates metrics like respiratory sinus arrhythmia, cardiac output, stroke volume, and stroke volume variability, providing critical insights into hemodynamic and autonomic function. The inclusion of direct-from-ECG metrics for sleep-related disorders, such as the apnea-hypopnea index, respiratory disturbance index, and oxygen saturation variability, underscores the protocol's utility in addressing the intersection of cardiopulmonary and sleep medicine. This multifaceted approach establishes a robust framework for precision diagnostics and holistic patient management. The COR 1.0 and COR 2.0 wearables provide multi-lead ECG recordings, with COR 2.0 offering extended capabilities for cardiopulmonary metrics and longer battery life (up to 14 days). COR 2.0 supports tri-modal operations: (i) Extended Holter Mode: Outputs Leads II and III, mirroring the functionality of COR 1.0 for broader ECG monitoring applications. (ii) Cardiopulmonary Mode: Adds real-time recording of Lead I, V2, respiratory impedance, and triaxial accelerometer outputs, providing advanced cardiopulmonary insights. (iii) Real-Time Streaming Mode: Streams data directly to mobile devices or computers via Bluetooth Low Energy (BLE), enabling real-time waveform rendering and analysis. The COR 2.0 units are experimental and not yet FDA-cleared. Primary endpoints include sensitivity (true positive rate) \> 80%, specificity (true negative rate) \> 90%, and statistical agreement with reference devices for cardiovascular, cardiopulmonary, and sleep metrics. Secondary endpoints focus on predictive values (PPV and NPV) and overall diagnostic performance. The study employs eight distinct sub-protocols (A through H) to address a variety of cardiovascular, cardiopulmonary, and sleep-related diagnostic goals. These sub-protocols are tailored to specific clinical endpoints, varying in duration (30 minutes to 14 days) and type of data collection. Up to 15,000 participants will be enrolled across multiple sub-protocols. Screening ensures eligibility, and subjects must provide informed consent before participation. Dropouts and non-compliant subjects will be excluded from final analyses.