Acute Coronary Syndrome Clinical Trial
Official title:
A Prospective, Multicenter, Observational Registry to Evaluate the Prevalence and Incidence of Cancer and Long-term Prognosis in Patients With Tako-Tsubo (Stress-induced) Cardiomyopathy.
Prospective, multicenter, observational registry collecting data from subjects with
Tako-Tsubo (stress-induced) cardiomyopathy (TTC). Uniform, complete, and accurate data will
be collected on the subject's medical history, during index hospitalization for TTC, and
during follow-up.
The objectives are to evaluate the prevalence and incidence of cancer in patients with TTC,
to document the underlying causes of death during hospital stay and during follow-up, to
determine the long-term prognosis, and to identify possible predictors of short and
long-term mortality.
The prognosis of patients with TTC is believed to be favorable. This assumption is mainly
based on the observations of a rapid recovery of global left ventricular function and low
cardiac in-hospital mortality. In fact, the clinical course following TTC events after
hospital discharge is largely unknown due to a lack of large prospective long-term follow-up
studies and inconsistent and limited findings from available studies to date.
The TTAC registry represents the first attempt to initiate an international registry with
special focus on comorbidities, particularly malignancies, in patients with TTC to further
elucidate the relationship between these diseases. In addition, the TTAC registry will
enable documenting the exact underlying causes of death and long-term prognosis of patients
with TTC and to identify possible predictors of short and long-term mortality in these
patients.
The first objective of this prospective, multicenter, observational registry is to evaluate
the prevalence and incidence of cancer in patients with TTC.
The second objective is to document the underlying causes of death during hospital stay and
follow-up and to determine the long-term prognosis of patients with TTC.
The third objective is to identify possible predictors of short and long-term mortality in
patients with TTC.
Available information is collected from subjects being treated according to routine clinical
practice. In addition, during the index hospitalization, each subject is screened for occult
cancer disease. During follow-up, cancer screening will be performed according to
appropriate legal preventive examinations.
Subjects will be followed at 6 months and annually after the index event for up to 5 years
by phone call, office visit, or by contacts with primary physicians or referring
cardiologists, according to each investigator's preference.
As regulated by data protection and privacy laws and in accordance with local ethics
committee requirements, subjects will be informed and requested to grant their approval
after the index procedure (= cardiac catheterization for suspected acute coronary syndrome)
to review their medical records and collect and analyze personal medical information. The
confidentiality of the records will be maintained at all times. Subjects will be asked to
agree to perform a cancer screening during index hospitalization and will also be asked to
agree to be contacted during the 5-year follow-up period.
Patients in whom TTC was diagnosed will be informed and requested to grant their approval to
review their medical records, to collect and analyze personal medical information, while
maintaining the confidentiality of the records at all times. Subjects will be asked to agree
to perform a cancer screening during index hospitalization and will also be asked to agree
to be contacted during the 5-year follow-up period. Informed consent will be requested after
the index procedure (= cardiac catheterization for suspected acute coronary syndrome proving
presence of TTC) and the informed consent form (ICF) has to be signed prior to entering
subject's data in the database or prior to any follow-up contact, whichever occurs first.
The investigator and/or designee must clearly document the process of obtaining informed
consent in the subject's source documents. The voluntary process of obtaining informed
consent confirms the subject's willingness to participate in the registry. It is the
investigator's responsibility to ensure that the informed consent process is performed in
accordance with Good Epidemiological Practice (GEP) - IEA Guidelines for proper conduct of
epidemiological research and where applicable country regulations.
Subjects will be followed at 6 months and annually after the index event for up to 5 years
by phone calls, office visits, or by contacts with general practitioners or referring
cardiologists, according to each investigator's preference.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06013813 -
Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI
|
N/A | |
Recruiting |
NCT05412927 -
AngelMed Guardian® System PMA Post Approval Study
|
||
Completed |
NCT02750579 -
Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes?
|
N/A | |
Completed |
NCT04102410 -
Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients
|
N/A | |
Enrolling by invitation |
NCT03342131 -
Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome
|
N/A | |
Recruiting |
NCT01218776 -
International Survey of Acute Coronary Syndromes in Transitional Countries
|
||
Enrolling by invitation |
NCT04676100 -
International CR Registry
|
||
Completed |
NCT03590535 -
5th Generation cTnT in ED ACS
|
||
Recruiting |
NCT05437900 -
INSIGHTFUL-FFR Clinical Trial
|
Phase 4 | |
Completed |
NCT05551429 -
Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
|
||
Terminated |
NCT04316481 -
IDE-ALERTS Continued Access Study
|
N/A | |
Active, not recruiting |
NCT04475380 -
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
|
||
Not yet recruiting |
NCT04852146 -
Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
|
||
Active, not recruiting |
NCT02892903 -
In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes?
|
N/A | |
Completed |
NCT04077229 -
Piloting Text Messages to Promote Positive Affect and Physical Activity
|
N/A | |
Completed |
NCT02944123 -
Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR)
|
Phase 3 | |
Not yet recruiting |
NCT02871622 -
BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM
|
N/A | |
Active, not recruiting |
NCT02922140 -
The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit
|
N/A | |
Terminated |
NCT02620202 -
Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain
|