Thrombus and Inflammation Study in Sudden Cardiac DEath (TIDE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00748111
First received: July 31, 2008
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

Sudden death is a natural death occurring within one hour after the onset of symptoms. It remains a major public health problem and accounts for 5 to 10 % of the annual total mortality ie about 300.000 in the United States. Despite community-based interventions, overall survival remains below 5%. Better understanding of the mechanisms causing sudden death could allow early identification of high risk subjects and implementation of specific prevention strategies. The cause of more than 90% of sudden deaths is cardiac with ventricular fibrillation or fast ventricular tachycardia complicating an underlying heart disease. Coronary heart disease and its consequences account for at least 80% of sudden cardiac deaths. Several risk factors associated with sudden death and not with myocardial infarction have been identified in population-based studies. However, the relationship between the occurrence of a coronary artery occlusion and the onset of arrhythmia is unclear. In particular, coronary artery occlusion can be rapidly followed by chest pain, which acts as a signal and allows identification of patients for emergency reperfusion. However, in some cases, the coronary artery occlusion is followed by a sudden onset of arrhythmia and sudden death. Recent data suggest that acute coronary occlusion is caused by plaque erosion or rupture and is followed by an intense local inflammation and rapid thrombus formation. Our hypothesis is that the speed of thrombus formation and coronary occlusion determines the clinical symptoms. Slow and progressive thrombus formation is likely to induce myocardial pre-conditioning thereby reducing the occurrence of ventricular arrhythmia. In contrast, rapid thrombus formation followed by acute coronary artery occlusion and ischemia is more likely to trigger fatal ventricular arrhythmia. During angioplasty procedures, coronary artery thrombus are aspirated, providing the opportunity for pathological studies. The aim of the TIDE study (Thrombus and Inflammation in Sudden Death) is therefore to compare the composition and age of thrombus collected at the site of coronary occlusion in patients with sudden death due to acute coronary artery occlusion and patients with an acute myocardial infarction without ventricular arrhythmia. The following hypothesis will be tested : fresh thrombus is more frequent in patients with sudden cardiac death versus patients with acute myocardial infarction without ventricular arrhythmia.


Condition Intervention
Sudden Cardiac Death
Acute Myocardial Infarction
Other: Blood sample

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Thrombus and Inflammation in Sudden Cardiac DEath

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Age of thrombus collected at the site of acute coronary occlusion. [ Time Frame: one day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local and systemic inflammation and endothelial cell apoptosis in patients with sudden death due to acute coronary occlusion, acute myocardial infarction and stable angina treated with coronary angioplasty. [ Time Frame: one day ] [ Designated as safety issue: No ]

Enrollment: 380
Study Start Date: August 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sudden cardiac death hospitalized
Other: Blood sample
Blood sample and thrombus sample
Other Name: Blood sample
Experimental: 2
Acute myocardial infarction
Other: Blood sample
Blood sample and thrombus sample
Other Name: Blood sample
Experimental: 3
Angioplasty procedures programmed
Other: Blood sample
Blood sample and thrombus sample
Other Name: Blood sample
Experimental: 4
Sudden cardiac death hospitalized without coronary syndrome
Other: Blood sample
Blood sample and thrombus sample
Other Name: Blood sample

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with sudden cardiac death without coronary artery occlusion
  • Patients with acute myocardial infarction due to coronary artery occlusion
  • Patients with stable angina treated with coronary angioplasty
  • Written informed consent
  • Social security

Exclusion Criteria:

  • Pregnancy
  • Small arteries that preclude the use of aspiration devices
  • Sudden death without coronary lesions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748111

Locations
France
Hopital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Xavier JOUVEN, MD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00748111     History of Changes
Other Study ID Numbers: P080201
Study First Received: July 31, 2008
Last Updated: December 10, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sudden death
Out of hospital cardiac arrest
Acute myocardial infarction
Acute coronary syndrome

Additional relevant MeSH terms:
Death
Infarction
Inflammation
Myocardial Infarction
Death, Sudden, Cardiac
Thrombosis
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heart Arrest
Death, Sudden
Embolism and Thrombosis

ClinicalTrials.gov processed this record on August 20, 2014