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Death, Sudden clinical trials

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NCT ID: NCT00692666 Completed - Stroke Clinical Trials

Letigen® and Cardiovascular Morbidity

Start date: May 2006
Phase: Phase 4
Study type: Observational

Letigen® was a combination drug containing ephedrine, an adrenergic agonist with lipolytic and appetite-inhibiting properties. The drug was used as adjuvant treatment of obesity from 1990 and up to 2002 when it was withdrawn from the market by the manufacturer. The basis for this was a number of spontaneous reports about patients that died during treatment with Letigen®. The causal relation has never been addressed. There are only sparse data from randomised studies and the above-mentioned reports are not conclusive. We propose a controlled study based on data from Statistics Denmark that hold a complete copy of the Prescription Register of the Danish Medicines Agency and the Danish Hospital Discharge Register. The aim of the study would be to determine whether there is an excess frequency of deaths and serious cardiovascular events that can not be explained by particular characteristics of users of the drug. A well-known problem in such observational studies is a fundamental incomparability between users and non-users of drugs. In the present setting, it should be expected that use of Letigen® is associated with high BMI, smoking, alcohol abuse, type-2 diabetes, mild hypertension, low physical activity and other indicators of unhealthy lifestyle. Thus, an uncritical comparison between users and non-users of Letigen® regarding serious cardiovascular events will probably show an excess frequency that can not necessarily be attributed to the drug. This problem can be addressed by a special epidemiological technique - the case-crossover design - which is particularly robust to such comparability problems. In brief, only cases should be included. Controls are the same persons at an earlier time, , where the case-defining disease has not yet developed. The exposure of cases will be compared with the exposure of the same persons' case history. To account for the effect of chronic exposure, we also perform, as a secondary analysis, a conventional case-control study nested within the cohort of Letigen users, and employing a risk-set sampling technique.

NCT ID: NCT00664807 Completed - Atrial Fibrillation Clinical Trials

Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)

GAME
Start date: April 2008
Phase: Phase 4
Study type: Observational

To generate a list of potential genetic markers that correlate with an increased risk of life-threatening arrhythmias. To evaluate ECG-based risk markers such as heart rate variability and T-wave Alternans for their association with arrhythmic events.

NCT ID: NCT00614718 Completed - Clinical trials for Ventricular Fibrillation

Failure of Chronically Implanted Defibrillator Leads -Incidence and Management

Start date: January 1993
Phase: N/A
Study type: Observational

Comparison of two different approaches to address the problem of malfunctioning ICD-leads. These leads consist of two parts. One that is used for detection of arrhythmias(and pacing if required) (Pace/Sense) and a second part that is used to deliver therapy is needed (Shock-coil). The two approaches compared are: Replacement of the entire lead in case of any lead malfunction versus placement of an additional pace/sense-lead if the shock-coil of the exiting lead was still functional.

NCT ID: NCT00570947 Completed - Clinical trials for Prevention of Sudden Death

CPR Prescription Program

Start date: December 2007
Phase: N/A
Study type: Interventional

In this study we hope to show that prescriptions provided for CPR Anytime™ to patients who are at risk for or have heart disease at three key locations, can motivate families to learn the skill. We will use our ED sites, an office based primary care setting, and an office based cardiology practice. Participants will be given the pharmacy locations where they can be purchased. Optimally they will complete the program at home with their family. Research Hypothesis: 1. Families of patients at risk for coronary artery disease can be motivated to learn CPR by receiving a prescription for a CPR Anytime ™ self learning kit. 2. As part of the multiplier effect, an additional 1.5 family members per participant are projected to be trained to perform CPR. 3. Families may experience a "teachable moment" when their loved one is in the emergency department. In comparison to the office settings, this may increase the likelihood that they fill the prescription for CPR Anytime® and complete the learning kit.

NCT ID: NCT00570869 Completed - Clinical trials for Prevention of Sudden Death

Training Mothers of Infants in Infant Cardiopulmonary Resuscitation (CPR)

Start date: January 2008
Phase: N/A
Study type: Interventional

This research will be a prospective, cohort study to determine if mothers of infants/newborns are more willing to complete CPR training using a 22-minute instructional DVD and infant manikin versus traditional four hour didactic instruction. Study Hypothesis: A 22-minute instructional DVD and infant manikin will be an effective and preferred tool for teaching mothers of infants infant CPR. Objectives 1. To determine if mothers of infants are more likely to complete infant CPR training with a 22-minute instructional DVD and infant manikin, than by attending a traditional CPR class. 2. To determine if learning infant CPR with a 22-minute instructional DVD and infant manikin is as effective as attending traditional infant CPR class. 3. To examine the number of mothers that were offered the opportunity to learn infant CPR either as part of their prenatal classes, or upon the birth of their infant. 4. To examine the number of mothers who have been previously trained in CPR. 5. To examine the reasons that mothers have been previously trained in CPR (e.g., mandated by work/career vs. personal reasons). 6. To examine the multiplier effect of an at home CPR education using a 22-minute instructional DVD and infant manikin at the time of the follow up phone call.

NCT ID: NCT00478933 Completed - Atrial Fibrillation Clinical Trials

DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.

DISCOVERY
Start date: February 2007
Phase: N/A
Study type: Interventional

To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify patients at risk of ventricular tachycardia. To evaluate the influence of ICD-based diagnostic information on the long term treatment and management of primary prevention ICD-patients.

NCT ID: NCT00439790 Completed - Heart Failure Clinical Trials

Sympathetic Nerve Activity and an Implantable Cardioverter Defibrillator in Heart Failure Patients

Start date: January 2007
Phase: N/A
Study type: Observational

The aim of this study is to analyze whether the sympathetic tone, measured indirectly and directly by muscle sympathetic nerve activity recording, is elevated in patients with heart failure receiving an appropriate shock from their implantable cardiac defibrillator (ICD) compared to heart failure patients not receiving a shock from their ICD. All parameters measured in this study will be used to build a risk algorithm able to identify heart failure patients at high risk for sudden cardiac death who could receive an ICD.

NCT ID: NCT00399503 Completed - Clinical trials for Myocardial Infarction

Assessment of Noninvasive Methods to Identify Patients at Risk of Serious Arrhythmias After a Heart Attack

Start date: September 2001
Phase: N/A
Study type: Observational

This study evaluates the usefulness of noninvasive tests of the structure of the heart and the nervous system controlling the heart. It will assess whether combining tests that evaluate heart structure with others that measure the nervous system controlling the heart will identify most patients who develop serious heart rhythm problems after a heart attack.

NCT ID: NCT00382928 Completed - Clinical trials for Ventricular Fibrillation

Automatic External Defibrillation Monitoring in Cardiac Arrest

Start date: October 2006
Phase: Phase 1
Study type: Interventional

We propose to randomize automatic external cardioverter/defibrillators (AECD) in patients who are at high risk for life-threatening abnormal heart rhythms (arrhythmias) and are admitted to the telemetry ward, all other treatments being constant including cardiopulmonary resuscitation. We hypothesize that the automatic, rapid, accurate and specific diagnostic and therapeutic technology used in AECDs will further increase the rate of survival in patients with cardiac arrest through rapid and automatic defibrillation, independent of operator initiation, as compared to standard cardiopulmonary resuscitation initiated by healthcare providers.

NCT ID: NCT00376532 Completed - Arrythmia Clinical Trials

Extracellular Matrix Marker of Arrhythmia Risk (EMMA)

EMMA
Start date: September 2006
Phase: N/A
Study type: Observational

Assess whether serum levels of MMP 2 and or MMP 9 correlate with episodes of ventricular tachycardia or fibrillation in patients who have implantable cardioverter defibrillator devices.