the study is to compare two newer intra coronary pressure measurements with standard Fractional Flow Reserve (FFR) for assesment of borderline coronary blockages.
- Conditions
- Health Condition 1: null- patients diagnosed with stable CAD as per AHA Guidelines11 and are taken up for coronary angiography
- Registration Number
- CTRI/2017/08/009537
- Lead Sponsor
- Dr Ajit Mullasari S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 120
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.
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 <40% measured by 2D echocardiography, regional wall motion abnormality in the area subtended by the intermediate coronary lesion, prior to the angiographic study.
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 <60 ml/mt
10.Patients with hypotension, systolic blood pressure <90mmHg at time of study
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 <0.98 or >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 <0.98 or >1.02, and absence of ECG or pressure-pullback recording.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method