Health Condition 1: null- patients diagnosed with stable CAD as per AHA Guidelines11 and are taken up for coronary angiography
Conditions
Interventions
Intervention1: who are diagnosed with stable CAD as per AHA (American Heart Association) Guidelines11 and are taken up for coronary angiography: The decision to treat the intermediate lesion is left t
Sponsors
Dr Ajit Mullasari S
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patient should be more than 18 years of age 2. They must be patients of stable angina or acute coronary syndromes (only non-culprit vessels and >48 h from symptoms onset in the case of myocardial infarction) taken up for invasive coronary angiography with or without percutaneous coronary intervention. 3. The coronary lesions considered for pressure studies must be ranging from 40-70% diameter stenosis in 1 or more native major epicardial vessel or its branches, at least 2 mm in diameter, as estimated by visual assessment.
Exclusion criteria
Exclusion criteria: 1. Patients with significant valvular pathology, previous coronary artery bypass surgery, coronary thrombus at the site of lesion, or in-stent restenosis. 2. Patients with ejection fraction 3. Extremely tortuous coronary arteries 4. Severely calcified coronary arteries 5. Left main coronary artery disease 6. Occluded coronaries 7. Patients with history of asthma/COPD or other contraindication to adenosine 8. Patients with history of contrast allergy 9. Patients with kidney diseases with derangements in eGFR 10. Patients with hypotension, systolic blood pressure 11. Patients with arrhythmias like ventricular tachyarrhythmia 12. Patients who are unwilling to participate in the study or sign the informed consent 13. Patients with the following during the core laboratory analysis also will be excluded from the study: inappropriate normalization of the pressure wire (Pd/Pa ratio 1.02), ECG artefacts or significant arrhythmias in the first 20 s of the recording (â??iFR calculation windowâ??), loss of Pa or Pd signals at any point during the recording, automatic calculation pitfalls (identification of FFR during ectopic beats, Pa or Pd noise, wire whipping artefacts, and so on), dampening of Pa or Pd waveforms, pressure drift higher than 1.02, and absence of ECG or pressure-pullback recording.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the diagnostic efficiencies of the pressure indices (rest Pd/Pa, iFR, contrast and Pd/Pa,) in relation to the reference standard- FFR, by a receiver-operator characteristic curve (ROC) analysis (AUC/ c-statistic), in intermediate coronary lesions determined angiographicallyTimepoint: Up to discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the linear correlation of the different pressure indices with FFR by Pearsonâ??s coefficients at ranges of FFR 0.6-0.9 and 0.75-0.80, by ROC analysis and Pearsonâ??s coefficients To derive at optimal cut-offs derived from ROC curves, for each of the pressure indices, to detect FFRâ?¤ 0.80 optimal cut-offs, as well as at certain pre-specified cut-offs in the whole cohort as well as in the cohorts with FFR 0.6-0.9 and FFR 0.75-0.85Timepoint: Time point will assessed at the time of discharge | — |
Countries
India
Contacts
Public ContactDr Ajit Mullasari
Institute of Cardio Vascular Diseases, The Madras Medical Mission
Outcome results
None listed