Identification of Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis (ENIGMAS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2012 by Carol Davila University of Medicine and Pharmacy
Sponsor:
Information provided by (Responsible Party):
MISCHIE Nicolae Alexandru, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier:
NCT01575249
First received: April 9, 2012
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

The investigators aim to identify all clinical, biological, echo and imagistic parameters that predispose to increased progression rates in a prospective observational trial which will include ONLY patients with moderate AS, with the complete cardiological investigational tools provided in 2012. Once those parameters are found, medical and interventional treatment could be implemented to decrease the mortality rates.


Condition
Aortic Stenosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Study Focused on idEntification of cliNical, Biological and Imagistic Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis

Resource links provided by NLM:


Further study details as provided by Carol Davila University of Medicine and Pharmacy:

Primary Outcome Measures:
  • occurrence of major adverse cardiac events (MACE) defined by the followings: death, aortic valve replacement (AVR) and myocardial infarction (MI). [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TIME TO SYMPTOMS (angina, dyspnea, syncope) at stress echocardiography [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • TIME TO ALTERED HEMODYNAMIC PARAMETERS at stress (strain decrease, EF decrease, ventricular arrhythmia, decrease in SBP, stress gradients suggestive of severe AS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • differentiate outcomes of patients with mean gradients between 40 and 50 mmHg (grey zone of AS) [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

standard blood count, c-reactive protein, urea, creatinin, hepatic standard biology, serum calcium, cholesterol and tryglicerides.


Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asymptomatic group
one hundred patients with a negative exercise stress echo for symptoms/ECG/wall motion abnormalities (WMA), negative spirometry test for pulmonary disease, without known CAD or other valvular diseases, in sinus rhythm and with a LVEF>55%
Symptomatic group
one hundred patients with symptomatic AS (negative pulmonary tests but positive stress echo or prior CAD or other valvular diseases and a LVEF>55%

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The enrollment will be done by echo screening of the population (of the 3rd Arrondissement in Bucharest, Romania) with age >50 years until target patients reached and also by screening out-patients arriving at "Bagdasar-Arseni" Emergency Hospital (Bucharest) with other cardiovascular diseases other than specified in the exclusion criteria.

Criteria

Inclusion Criteria:

  • age 21 years;
  • native aortic valve leaflet thickening with reduced systolic opening on two-dimensional echocardiography and an aortic jet velocity at rest between 2.8 and 3.1 m/s or a valve area calculated by the continuity equation of 1.7 to 1.5 cm2, evaluated at a heart rate between 60 and 90/ minute and at a systolic arterial pressure of 120-140mmHg at baseline;
  • LVEF > 55% (calculated by modified Simpson formula).

Exclusion Criteria:

  • positive stress test (symptoms including dyspnoea, angina, syncope, ECG pathological changes, WMA);
  • positive pulmonary disease (spirometry);
  • heart failure;
  • LVEF < 55%;
  • moderate/severe aortic or mitral regurgitation or mitral stenosis, subvalvular or supravalvular AS, dynamic subaortic obstruction;
  • CAD (history of MI or coronary artery stenosis on coronary angiography);
  • active endocarditis;
  • rhythm other than sinus rhythm;
  • severe uncontrolled risk factors for CAD:

    • uncontrolled DM,
    • uncontrolled hypertension (SBP > 180mmHg),
    • refuse to discontinue smoking,
    • persistent hypercholesterolemia under treatment (total cholesterol > 240mg/dl);
  • glomerular filtration rate < 30% or patient requiring dialysis;
  • patient refusal; survival expectancy < 2 years;
  • inability to perform physical exercise;
  • suboptimal echo window;
  • different types of echo machines.
  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: NCT01575249

Locations
Romania
"Bagdasar-Arseni" Emergency Hospital Not yet recruiting
Bucharest, Romania, 041915
Contact: ALEXANDRU N MISCHIE, MD    0040723708050    alexandru_mischie@yahoo.com   
Principal Investigator: ALEXANDRU N MISCHIE, MD         
Principal Investigator: CRINA SINESCU, MD FESC FACC         
Sponsors and Collaborators
Carol Davila University of Medicine and Pharmacy
Investigators
Principal Investigator: ALEXANDRU N MISCHIE, MD BAGDASAR ARSENI EMERGENCY HOSPITAL
  More Information

Additional Information:
No publications provided

Responsible Party: MISCHIE Nicolae Alexandru, CARDIOLOGIST, ASSISTANT PROFESSOR, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT01575249     History of Changes
Other Study ID Numbers: The ENIGMAS trial
Study First Received: April 9, 2012
Last Updated: April 10, 2012
Health Authority: Romania: Ministry of Public Health

Keywords provided by Carol Davila University of Medicine and Pharmacy:
progression
moderate aortic stenosis
asymptomatic
symptomatic

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 18, 2014