Thrombus and Inflammation Study in Sudden Cardiac DEath

NCT00748111 | Completed

• 1 other identifier: P080201
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sudden Cardiac Death; Acute Myocardial Infarction

Keywords

Sudden death; Out of hospital cardiac arrest; Acute myocardial infarction; Acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• Age of thrombus collected at the site of acute coronary occlusion.

  one day

Secondary Outcomes (1)

• 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.

  one day

Study Arms (4)

1

EXPERIMENTAL

Sudden cardiac death hospitalized

Other: Blood sample

2

EXPERIMENTAL

Acute myocardial infarction

Other: Blood sample

3

EXPERIMENTAL

Angioplasty procedures programmed

Other: Blood sample

4

EXPERIMENTAL

Sudden cardiac death hospitalized without coronary syndrome

Other: Blood sample

Interventions

Blood sample OTHER

Blood sample and thrombus sample

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Small arteries that preclude the use of aspiration devices
• Sudden death without coronary lesions

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hopital Cochin

Paris, 75014, France

Location

Related Publications (1)

• Empana JP, Boulanger CM, Tafflet M, Renard JM, Leroyer AS, Varenne O, Prugger C, Silvain J, Tedgui A, Cariou A, Montalescot G, Jouven X, Spaulding C. Microparticles and sudden cardiac death due to coronary occlusion. The TIDE (Thrombus and Inflammation in sudden DEath) study. Eur Heart J Acute Cardiovasc Care. 2015 Feb;4(1):28-36. doi: 10.1177/2048872614538404. Epub 2014 Jun 9.

  PMID: 24912925 RESULT

MeSH Terms

Conditions

Death, Sudden, Cardiac; Death, Sudden; Out-of-Hospital Cardiac Arrest; Acute Coronary Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Xavier JOUVEN, MD

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: September 8, 2008
• Study Start: August 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

FR (1)