A Pilot Study of Transcoronary Myocardial Cooling

Status Completed

Clinical Trial Summary

Patients with heart attacks caused by blocked coronary arteries are usually treated with a technique called primary angioplasty. Although this treatment is very successful it can result in damage to the heart muscle when the artery is opened due to reperfusion injury. Cooling the entire body has been shown to reduce heart muscle damage during heart attacks in some patients but not in others, however it is uncomfortable due to the shivering, expensive and can result in delays in opening the blocked artery. We are investigating a simpler way to cool the heart muscle directly using cooled fluid passed through the catheter without the shortcomings of entire body cooling. This pilot will address safety and feasibility considerations.

Clinical Trial Description

The precise mechanisms involved in ischaemia/reperfusion injury is not fully understood but a number of factors are thought to contribute to cardiac dysfunction14, 15. These include : 1. reperfusion arrhythmias; 2. microvascular obstruction or no-reflow phenomenon; 3. myocardial stunning and 4. cardiomyocyte apoptosis. It is estimated that ischaemia/reperfusion injury occurs in > 30% of patients and is associated with reduced myocardial salvage and poor prognosis16-18. Ischaemia/reperfusion injury may account for up to 50% of the final infarct size9.

Deep hypothermia (< 30 °C) has long been used in protecting the heart during coronary artery bypass grafting and heart transplantation. Intermittent antegrade or retrograde infusion of cold cardioplegia appears to reduce myocardial ischaemia and improves outcome19, 20. Deep hypothermia however can cause spontaneous ventricular fibrillation and impaired cardiac function and its application is limited to the unconscious patient. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02312336
Study type	Interventional
Source	Royal Brompton & Harefield NHS Foundation Trust
Contact
Status	Completed
Phase	N/A
Start date	September 2014
Completion date	July 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04451967` - Acute Myocardial Infarction Study in Northeastern China
Completed	`NCT05974397` - Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan
Not yet recruiting	`NCT04072081` - Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions	N/A
Recruiting	`NCT03940443` - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting	`NCT03707626` - Collateral Circulation to LAD and Wellens Sign
Completed	`NCT02669810` - EXCELLENT (EXpanded CELL ENdocardiac Transplantation)	Phase 2
Not yet recruiting	`NCT04104048` - Short Term Outcome of Primary Precutaneous Coronary Intervention in Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
Active, not recruiting	`NCT02915107` - The SORT OUT IX STEMI OCT Trial	N/A
Completed	`NCT02896543` - The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction	N/A
Completed	`NCT02490969` - Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19	N/A
Completed	`NCT02531165` - Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention	N/A
Withdrawn	`NCT01901471` - Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock	Phase 2
Recruiting	`NCT02071342` - Study of ABSORB Stent in Acute Myocardial Infarction	N/A
Completed	`NCT02070913` - COOL-AMI EU Case Series Clinical Study
Terminated	`NCT01972126` - MAGNetic QRS-Fragmentation in Patients With Myocardial InfarcTion and Moderately RedUceD Ejection Fraction	N/A
Completed	`NCT01216995` - Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)	Phase 2
Completed	`NCT01887080` - Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program	N/A
Withdrawn	`NCT01678339` - Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients	N/A
Completed	`NCT01325116` - Delayed Educational Reminders in Acute Myocardial Infarction (MI)	N/A
Completed	`NCT01627457` - Heart Cycle Prestudy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.