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Microvascular Function in Non-ST-segment Elevation Acute Coronary Syndrome

Microvascular Function in Non-ST-segment Elevation Acute Coronary Syndrome - DEFINE NSTEMI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42844
Enrollment
60
Registered
2016-11-15
Start date
2017-02-02
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

microvascular dysfunction NSTEMI

Interventions

Doppler coronary flow
NSTEMI
Thermodilution coronary flow

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Stable angina (CCS class I to III, or Braunwald class I) or NSTE-ACS (Chest pain within the preceding 5 days and an index event >24 hours from time of angiography but within the previous 7 days).;2. Scheduled for percutaneous coronary intervention or intracoronary evaluation of functional stenosis severity (diagnostic catheterization).;3. The presence of at least one normal or minimally diseased reference coronary artery (

Exclusion criteria

Exclusion criteria: 1. Younger than 19 or older than 80 years of age.;2. Recent ST-segment elevation myocardial infarction (13 mm).;7. Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements.;8. Women of child bearing age not on active birth control;9. Inability to sign an informed consent, due to any mental condition that renders the subject unable to understand the nature, scope, and possible consequences of the trial or due to mental retardation or language barrier.

Design outcomes

Primary

MeasureTime frame
To document the magnitude of microvascular resistance in patients with NSTE-ACS versus patients with stable coronary artery disease, as obtained from Doppler flow velocity-derived and thermodilution mean transit time-derived surrogates of coronary flow.

Secondary

MeasureTime frame
To document the relative magnitude of absolute coronary flow and coronary flow reserve in patients with NSTE-ACS versus patients with stable coronary artery disease, as obtained from Doppler flow velocity-derived and thermodilution mean transit time-derived surrogates of coronary flow. To determine the relationship between Doppler flow velocity-derived and thermodilution-derived mean transit time-derived surrogates of coronary flow, coronary flow reserve, and the derived indices of microvascular resistance. To determine the effect of intravenous versus intracoronary administration of adenosine on maximal coronary flow and coronary flow reserve. To determine the relevance of correction of coronary flow and coronary flow reserve for the loss of perfusion pressure after intravenous administration of adenosine. To determine the potential of advanced analysis of the coronary angiogram for the assessment of coronary flow and resistance parameters through fluid dynamic modelling.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)