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Comparison of the efficacy of intracoronary sodium nitroprusside injection versus intracoronary adenosine injection for fractional flow reserve (FFR) measurement in moderately stenotic coronary lesions during diagnostic coronary angiography

Comparison of the efficacy of intracoronary sodium nitroprusside injection versus intracoronary adenosine injection for fractional flow reserve (FFR) measurement in moderately stenotic coronary lesions during diagnostic coronary angiography: an open-label, non-inferiority clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251005067509N1
Enrollment
52
Registered
2025-10-14
Start date
2025-11-22
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

?????? ???? ?????. Atherosclerotic heart disease of native coronary artery

Interventions

Intervention group: In this trial, patients who have defined indications for coronary angiography (at the discretion of the interventional cardiologist) will undergo invasive coronary angiography. In

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with moderately stenotic (50%-70%) coronary lesions (non-Left main branch) in invasive coronary angiography who are candidates for physiologic assessment with FFR (Fractional Flow Reserve) measurement Informed and written consent by the patient in order to participate in the trial

Exclusion criteria

Exclusion criteria: Left main coronary lesion Acute or previous myocardial infarction in the past week Patients with acute decompensated heart failure Patients diagnosed with Heart failure (HF) and Left ventricular ejection fraction less than 35% Severe renal dysfunction (estimated Glomerular filtration rate (eGFR) less than 30 mL/min) according to Cockcroft-Gault formula Patients with systolic blood pressure less than 90 mm Hg and/or diastolic blood pressure less than 60 mm Hg More than one lesion in the evaluated target vessel Hypersensitivity to adenosine or any component of the formulation Sick sinus syndrome Second- or third-degree AV block Symptomatic bradycardia History of bronchoconstrictive or bronchospastic lung disease such as asthma Use of aminophylline/theophylline in the past 24 hours Use of dipyridamole Preexcited atrial fibrillation/flutter Hypersensitivity to nitroprusside or any component of the formulation Use of sildenafil/tadalafil in the past 72 hours Liver disease (cirrhosis, liver failure) History of Cerebrovascular accident (CVA) in the past month Anemia with Hemoglobin less than 11 mg/dL

Design outcomes

Primary

MeasureTime frame
Fractional Flow Reserve. Timepoint: Immediately after intracoronary injection of Adenosine and also immediately after intracoronary injection of Sodium Nitroprusside. Method of measurement: Intracoronary Pressure Guide Wire.

Secondary

MeasureTime frame
Adverse drug reactions. Timepoint: during and after intracoronary adenosine and nitroprusside injection. Method of measurement: Patient monitoring during and after drug injection.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Mehrpooya

Tehran University of Medical Sciences

maryammehrpooya1@gmail.com+98 21 6619 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026