A Registry to Determine the Clinical and Genetic Risk Factors for Torsade De Pointes

NCT02439645 | Terminated DMC

• 1 other identifier: 2013P001531
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 4

Brief Summary

This is a registry to examine genetic and clinical predictors of torsade de pointes events.

Conditions

Long qt Syndrome; Torsade de Pointes

Keywords

genetic research

Outcome Measures

Primary Outcomes (1)

• Torsade de pointes arrhythmia events

  1. Definite TdP: At least 3 beats of polymorphic ventricular tachycardia (VT) or ventricular fibrillation (VF) on a 12-lead ECG or rhythm strip with documented QTc \> 450 ms in men or QTc \> 470 in women (excluding patients with conduction block or AF at baseline, see below) prior to arrhythmic event. 2. Probable TdP: At least 3 beats of polymorphic VT or VF on a 12-lead ECG or rhythm strip with QTc \> 450ms (men) or 470ms (women) after the event, or polymorphic VT or VF episode not meeting criteria for 'definite TdP' but determined by the adjudicating physician to be likely TdP. For patients having a cardiac arrest, at least 1 hour after restoration of normal rhythm or after secondary hypoxia or electrolyte abnormalities have been ruled out (confounders of QT prolongation often seen post-arrest47) will be required. 3. Possible TdP: Unexplained syncope in a patient presenting with QTc \> 450ms (men) or 470ms (women).

  Participants will be followed for the time to obtain consent, clinical information and biospecimens (typically < 1 day)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient in which informed consent can be obtained, with a history of torsade de points (see below designation).

You may not qualify if:

• age \<18 years old
• inability to obtain informed consent from the patient or a family member
• torsade de pointes clinical syndrome according to one of the following three clinical criteria:
• Definite TdP: At least 3 beats of polymorphic ventricular tachycardia (VT) or ventricular fibrillation (VF) on a 12-lead ECG or rhythm strip with documented QTc \> 450 ms in men or QTc \> 470 in women (excluding patients with conduction block or AF at baseline, see below) prior to arrhythmic event.
• Probable TdP: At least 3 beats of polymorphic VT or VF on a 12-lead ECG or rhythm strip with QTc \> 450ms (men) or 470ms (women) after the event, or polymorphic VT or VF episode not meeting criteria for 'definite TdP' but determined by the adjudicating physician to be likely TdP. For patients having a cardiac arrest, at least 1 hour after restoration of normal rhythm or after secondary hypoxia or electrolyte abnormalities have been ruled out (confounders of QT prolongation often seen post-arrest47) will be required.
• Possible TdP: Unexplained syncope in a patient presenting with QTc \> 450ms (men) or 470ms (women).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• US Department of Veterans Affairs: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• Boston University: collaborator
• Mayo Clinic: collaborator
• The Cleveland Clinic: collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

West Roxbury VA Medical Center

West Roxbury, Massachusetts, 02132, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from patients with a history of torsade de pointes.

MeSH Terms

Conditions

Long QT Syndrome; Torsades de Pointes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular; Tachycardia

Study Officials

• Christopher Newton-Cheh, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Overall Principal Investigator

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 12, 2015
• Study Start: October 1, 2013
• Primary Completion: July 26, 2019
• Study Completion: July 26, 2019
• Last Updated: December 3, 2021

Record last verified: 2021-11

Locations

US (4)