International Survey of Acute Coronary Syndromes in Transitional Countries (ISACS-TC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University of Bologna
Sponsor:
Information provided by (Responsible Party):
Raffaele Bugiardini, University of Bologna
ClinicalTrials.gov Identifier:
NCT01218776
First received: October 7, 2010
Last updated: August 18, 2016
Last verified: August 2016
  Purpose
The International Registry of Acute Coronary Syndromes registry study in Transitional Countries (ISACS-TC) is both a retrospective and prospective study which was designed in order to obtain data of patients with acute coronary syndromes in countries with economy in transition, and herewith control and optimize internationally guideline recommended therapies in these countries Further study details as provided by the CINECA http://isacs-ct.cineca.org/

Condition
Acute Coronary Syndrome
Unstable Angina Pectoris
Myocardial Infarction
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Survey of Acute Coronary Syndromes in Transitional Countries

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • All causes mortality [ Time Frame: 30 days, 6 months, 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cardiovascular mortality [ Time Frame: 30 days, 6 months, 1 year ] [ Designated as safety issue: Yes ]
  • Recurrent myocardial infarction [ Time Frame: 30 days, 6 months, 1year ] [ Designated as safety issue: Yes ]
  • Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes [ Time Frame: 6 month, 1 year ] [ Designated as safety issue: No ]
  • Adherence to internationally guideline recommended therapies across the participating countries [ Time Frame: discharge, 6 months, 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, white cells,

Estimated Enrollment: 24000
Study Start Date: September 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Male, Female, Kidney Disease, Elderly

Detailed Description:

Aims of this survey study are (1) documentation of the characteristics of all patients presenting to the ISACS-TC centers with STEMI or NSTEMI (2) documentation of in-hospital outcome, and outcome rates at 6 month and 1 year, (3) documentation of invasive procedures and procedure-associated complications (4) documentation of therapeutic regimens and investigation conformity of treatment with already established guidelines.

Further study details as provided by the CINECA http://isacs-ct.cineca.org/

Investigators:

ISACS-TC Administrative Committee:

Raffaele Bugiardini (Italy-Principal Investigator) Lina Badimon (Spain) Viola Vaccarino (United States-Project Director) Olivia Manfrini (Italy- Project Coordinator) Edina Cenko (Italy-Center Coordinator)

Honorary President: Valentin Fuster

Steering Committee:

Nicolay Manak and Irena Karpova (Belorussia), Mirza Dilic and Dijana Trninic(Bosnia and Herzegovina), Asen Goudev (Bulgaria), Davor Milicic (Croatia), Kalman Toth (Hungary), Irfan Daullxhiu (Kosovo), Andrejs Erglis and Ilja Zakke (Latvia), Remigius Zaliunas and Olivija Gustiene (Lithuania), Sasko Kedev (FYR Macedonia), Mihail Popovici (Moldova), Bozidarka Knezevic (Montenegro), Sergei Boytsov and Valery Gafarov(Russian Federation), Maria Dorobanty (Romania), Zorana Vasiljevic and Miodrag Ostojic (Serbia), Eva Goncalvesova and Martin Studenkan (Slovakia) , Alexander N. Parkhomenko (Ukraine) , Alistair Hall and Christopher P Gale (United Kingdom).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects admitted with a diagnosis of acute coronary syndromes.
Criteria

Inclusion Criteria:

  • acute coronary syndromes

Exclusion Criteria:

  • under age or not able to give informed consent
  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: NCT01218776

Contacts
Contact: Raffaele Bugiardini, MD +39 335 5612962 raffaele.bugiardini@unibo.it
Contact: Lina Badimon, MD +34 670296741 badimon@csic-iccc.org

Locations
Italy
University of Bologna Recruiting
Bologna, Emilia Romagna, Italy, 40138
Contact: Raffaele Bugiardini, MD    +39 335 5612962    raffaele.bugiardini@unibo.it   
Contact: Lina Badimon, MD    +34 670296741    lbadimon@csic-iccc.org   
Principal Investigator: Raffaele Bugiardini, MD         
Sponsors and Collaborators
University of Bologna
Investigators
Principal Investigator: Raffaele Bugiardini, MD University of Bologna
  More Information

Additional Information:
CINECA  This link exits the ClinicalTrials.gov site

Publications:
Manfrini O, Dorobantu M, Vasiljevic Z, Kedev S, Knežević B, Miličić D, Dilic M, Trninic D, Daullxhiu I, Gustienė O, Ricci B, Martelli I, Cenko E, Koller A, Badimon L, Bugiardini R. Acute coronary syndrome in octogenarian patients: results from the international registry of acute coronary syndromes in transitional countries (ISACS-TC) registry. Eur Heart J Suppl.2014;16 (suppl A): A87-A94. DOI: http://dx.doi.org/10.1093/eurheartj/sut019. First published online: 10 January 2014
Cenko E, Ricci B, Kedev S, Vasiljevic Z, Dorobantu M, Gustiene O, Knežević B, Miličić D, Dilic M, Trninic D, Smith F, Manfrini O, Badimon L, Bugiardini R. Reperfusion therapy for ST-elevation acute myocardial infarction in Eastern Europe: the ISACS-TC registry. Eur Heart J Qual Care Clin Outcomes. 2016; 2:45-51. DOI: http://dx.doi.org/10.1093/ehjqcco/qcv025 First published online: 27 October 2015.
Bugiardini R, Badimon L , Manfrini O. Rationale and design of the ISACS-TC (International Survey of Acute Coronary Syndromes in Transitional Countries) project. Eur Heart J Suppl. 2014;16 (suppl A): A1-A6 DOI: http://dx.doi.org/10.1093/eurheartj/sut002. First published online: 10 January 2014
Dorobantu M, Tautu O.-F, Fruntelata A, Calmac L, Tatu-Chitoiu G, Bataila V, Dimulescu D, Craiu E, Nanea T, Istvan A, Babes K, Macarie C, Militaru C, Cenko E, Manfrini O. Hypertension and acute coronary syndromes in Romania: Data from the ISACS-TC registry. Eur Heart J Suppl (2014) 16 (suppl A): A20-A27 DOI: http://dx.doi.org/10.1093/eurheartj/sut006 First published online: 10 January 2014
Vasiljevic Z, Krljanac G, Davidovic G, Panic G, Radovanovic S, Mickovski N, Srbljak N, Markovic-Nikolic N, Curic-Petkovic S, Panic M, Cenko E, Manfrini O, Martelli I, Koller A, Badimon L, Bugiardini R. Gender differences in case fatality rates of acute myocardial infarction in Serbia. Eur Heart J Suppl (2014) 16 (suppl A): A48-A55 DOI: http://dx.doi.org/10.1093/eurheartj/sut012 First published online: 10 January 2014
Trninic D, Dilic M, Vasiljevic Z, Kulic M, Srdić S, Dobrijević N, Sabanovic-Bajramovic N, Begic A, Kukavica N, Vukcevic V, Davidovic G, Panic G, Saric J, Zrnic M, Matic I, Trifunovic N, Martelli I, Cenko E, Manfrini O, Koller A, Badimon L, Bugiardini R. Clinical profile of patients with no-reperfusion therapy in Bosnia and Herzegovina and Serbia. Eur Heart J Suppl (2014) 16 (suppl A): A67-A73 DOI: http://dx.doi.org/10.1093/eurheartj/sut015 First published online: 10 January 2014
Knežević K, Vasiljevic V, Music L, Krivokapic L, Ljubic V, Cvijovic Tomic S, Omer S, Radojicic S, Radoman C, Rajovic G, Riger L, Saranovic M, Velickovic M, Rajic D, Zivkovic S, Lasica R, Bankovic-Milenkovic N, Ljubica D, Jovanovic D, Jelica J, Radakovic R, Zdravkovic Z, Ricci B, Manfrini O, Martelli I, Koller A, Badimon L, Bugiardini R. Management of heart failure complicating acute coronary syndromes in Montenegro and Serbia. Eur Heart J Suppl (2014) 16 (suppl A): A61-A66 DOI: http://dx.doi.org/10.1093/eurheartj/sut014 First published online: 10 January 2014

Responsible Party: Raffaele Bugiardini, Principal Investigator, University of Bologna
ClinicalTrials.gov Identifier: NCT01218776     History of Changes
Other Study ID Numbers: ISACS-TC 1 
Study First Received: October 7, 2010
Last Updated: August 18, 2016
Health Authority: Italy: Ministry of Health

Keywords provided by University of Bologna:
Acute Coronary Syndrome, Eastern Europe, Therapies

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Syndrome
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Angina, Unstable
Disease
Pathologic Processes
Ischemia
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 29, 2016