Identification of Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis (ENIGMAS)
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ClinicalTrials.gov Identifier: NCT01575249 |
Recruitment Status : Unknown
Verified April 2012 by MISCHIE Nicolae Alexandru, Carol Davila University of Medicine and Pharmacy.
Recruitment status was: Not yet recruiting
First Posted : April 11, 2012
Last Update Posted : April 11, 2012
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Condition or disease |
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Aortic Stenosis |

Study Type : | Observational |
Estimated Enrollment : | 200 participants |
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 |
Study Start Date : | July 2012 |
Estimated Primary Completion Date : | January 2016 |
Estimated Study Completion Date : | June 2016 |

Group/Cohort |
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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%
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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%
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- occurrence of major adverse cardiac events (MACE) defined by the followings: death, aortic valve replacement (AVR) and myocardial infarction (MI). [ Time Frame: 3 years ]
- TIME TO SYMPTOMS (angina, dyspnea, syncope) at stress echocardiography [ Time Frame: 3 years ]
- 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 ]
- differentiate outcomes of patients with mean gradients between 40 and 50 mmHg (grey zone of AS) [ Time Frame: 6 years ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 50 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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;
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575249
Romania | |
"Bagdasar-Arseni" Emergency Hospital | |
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 |
Principal Investigator: | ALEXANDRU N MISCHIE, MD | BAGDASAR ARSENI EMERGENCY HOSPITAL |
Responsible Party: | MISCHIE Nicolae Alexandru, CARDIOLOGIST, ASSISTANT PROFESSOR, Carol Davila University of Medicine and Pharmacy |
ClinicalTrials.gov Identifier: | NCT01575249 |
Other Study ID Numbers: |
The ENIGMAS trial |
First Posted: | April 11, 2012 Key Record Dates |
Last Update Posted: | April 11, 2012 |
Last Verified: | April 2012 |
progression moderate aortic stenosis asymptomatic symptomatic |
Aortic Valve Stenosis Constriction, Pathologic Disease Progression Pathological Conditions, Anatomical Disease Attributes |
Pathologic Processes Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |